Parexel Jobs in the United States
Parexel
Olympia, WA
7+ years experience in pharmaceutical/biotech clinical data management / Biometrics (clinical trial data and/or Real World Data) + Medical affairs experience (Phase IIIB - IV trials experience); Late Phase Oncology + Strong project management experience + Demonstrated collaboration and superb communication skills, both written and oral (proficiency in English required). + Experience in leading DM study teams, overseeing trial data activities, and collecting clinical trial and/or Real World Data, with a good understanding of molecule and disease area strategies and the healthcare environment.
Parexel
Olympia, WA
Individuals selected for these roles will provide leadership to project teams and manage the day-to-day operations while striving to achieve operational excellence through on time delivery within budget and to the highest quality with the goal to exceed client expectations Successful candidates possess an undergraduate degree in a clinical or health related field: advanced degree preferred, along with at minimum, 2+ years' experience leading Global Clinal Trials in Project Management within a CRO (preferred), Biotech or Pharma company. As a part of the Global Project Leadership organization, your work has a direct impact on the projects, teams, and clients you work with, while helping deliver projects to the benefit of the patients we serve.
Parexel
Olympia, WA
Parexel has upcoming future opportunities at the Project Leader (PM) and Senior Project Leader (SPM) level for candidates with experience leading global studies in a variety of therapeutics including Oncology (Hematology), Respiratory / General Medicine and Obesity/Endocrine** Individuals selected for these roles will provide leadership to project teams and manage the day-to-day operations while striving to achieve operational excellence through on time delivery within budget and to the highest quality with the goal to exceed client expectations Successful candidates possess an undergraduate degree in a clinical or health related field: advanced degree preferred, along with at minimum, 2+ years' experience leading Global Clinal Trials in Project Management within a CRO (preferred), Biotech or Pharma company. As a part of the Global Project Leadership organization, your work has a direct impact on the projects, teams, and clients you work with, while helping deliver projects to the benefit of the patients we serve.
Parexel
Olympia, WA
7+ years experience in pharmaceutical/biotech clinical data management / Biometrics (clinical trial data and/or Real World Data) + Medical affairs experience (Phase IIIB - IV trials experience); Late Phase Oncology + Strong project management experience + Demonstrated collaboration and superb communication skills, both written and oral (proficiency in English required). + Experience in leading DM study teams, overseeing trial data activities, and collecting clinical trial and/or Real World Data, with a good understanding of molecule and disease area strategies and the healthcare environment.
Parexel
Olympia, WA
Parexel is seeking a **Principal Real World Research Delivery Lead (RWRDL)** to join our team and deliver innovative Real World Research (RWR) solutions for global clients. In this role, you'll **lead cross-functional teams** , manage **budgets and timelines** , and serve as the **primary client contact** for innovative RWD projects.
Parexel
Olympia, WA
Responsibilities** + Experience in routine and real-time testing for high-performance liquid chromatography (HPLC), gas chromatography (GC), ultraviolet (UV) spectroscopy, infrared (IR) spectroscopy, titrations, Karl Fischer (KF) testing, and other wet chemistry methods + Experience in HPLC and GC is required with an interest in expanding the knowledge and background in method development and optimization, validation, data analysis, and sample preparation techniques + Routine use of modern analytical techniques such as HPLC, GC, KF, ultraviolet-visible spectroscopy (UV-VIS), and IR spectroscopy + Comfortable working in a cGMP environment; knowledgeable in various GMP analytical activities, such as documentation procedures, abiding by relevant department SOPs and generation and second scientist review of GMP data + Experience with automated liquid handling systems (Tecan) for high throughput testing + Experience with a myriad of software platforms used in the compilation, processing, and reporting of data, such as Waters Empower, Relational Laboratory Information Management System (RLIMS), Lab X, etc. **Qualifications** + BA/BS (3-5 yrs.) of relevant experience in n chemistry or a related discipline testing lab + MS (1-2 yrs.) of relevant experience in chemistry or a related discipline testing lab **Desired Skills and Experience** + Effective organizational, multi-tasking, and oral/written communications skills + Ability to work under pressure and provide reliable results with quick turnarounds + Consistently deliver high quality and fully compliant results and interact with a diverse customer base daily + Proficient in written and spoken English, is required **About Parexel** Parexel FSP includes the CMC Operations group.
Parexel
Olympia, WA
Follows quality issue processes by escalating systematic or serious quality issues, data privacy breaches, Clinical Study Protocol (CSP) or ICH-GCP compliance issues to Local Management and/or Clinical Quality Management (CQM) as required. The CRA is responsible for the preparation, initiation, monitoring, and closure of assigned sites in clinical studies, in compliance with Client Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations and that the sites deliver according to their respective commitment in the individual studies.
Parexel
Olympia, WA
Principal Biostatistician (Patient-Reported Outcomes Focus)** _Remote- US | Full-Time_ **About the Role** The Principal Biostatistician works independently across clinical trial projects of all complexity levels, including those with major regulatory impact. The ideal candidate is a strong communicator, trusted advisor, and technical leader capable of driving statistical strategy and execution across multiple therapeutic areas.
Parexel
Durham, NC
Technology: ER/Studio, Oracle, Azure SQL, Azure Synapse, and Qlik Compose or other Data Warehouse Automation tools, Microsoft Azure PaaS (or similar cloud platforms), IaaS and related data and integration services, Azure Data Factory, DataBricks, PowerBI, and PowerApp. Who we are looking for : Curious individuals with previous experience working with data to contribute to the overall data models and define principles, designs, and models that drive information sharing across the enterprise.
Parexel
Olympia, WA
Key Accountabilities** : **Author Clinical Documents** + Gather, review, analyze, and evaluate pertinent resources to prepare, develop, and finalize clinical documents for submission to regulatory authorities, including but not limited to: briefing documents, investigator brochures, study protocols, model informed consents, interim and final clinical study reports, common technical document (CTD) clinical overviews and summaries, safety update/aggregate reports, and integrated summaries of safety and efficacy. + Serve as the Medical Writing representative on assigned project teams and demonstrate document leadership: communicate content requirements, coordinate and conduct interdepartmental team review of draft and final documents, schedule and lead/facilitate authoring team meetings to agree on expectations, evaluate progress on tasks, identify issues and facilitate resolutions, manage/drive the timeline, and advance document development to approval, according to Parexel or client guidelines/SOPs.
Parexel
Olympia, WA
This is a dynamic position that demands deep regulatory expertise, strong project management capabilities, and the ability to effectively influence cross-functional teams in a fast-changing environment. We are currently seeking a highly motivated Regulatory Affairs professional to join Parexel and contribute their knowledge of FDA regulatory requirements and processes to a major, dedicated client partnership.
Parexel
Olympia, WA
Are you experienced in leading the strategy behind how life-changing therapies are communicated to the world, ensuring innovative products are supported by clear, compliant, and high-quality documentation that enables safe and effective use across global markets? Parexel is seeking an experienced and highly motivated **Global Regulatory Labeling Lead** to provide strategic leadership and operational oversight for complex global labeling initiatives.
Parexel
Olympia, WA
Presents to client boards and provide strategic advice to the C suite + Plans and delivers services and solutions which results in clients expressing satisfaction with service provided and build relationships which results in additional business or referrals + Identifies opportunities for follow-on business or changes in project scope and exploits the opportunities with RS management and account management Requirements + Education - MD required + Minimum Work Experience - 15+ years experience with expert level industry or regulatory knowledge experience in Clinical Development/Clinical Trial Design, Clinical Strategy, and expertise in reviewing and evaluating clinical sections of regulatory applications. Project Execution + Works within a team environment or individually based on project needs + Works within broad project guidelines and leads issue and conflict resolution + Prioritizes own workload and prioritizes the workload of the project team to achieve the project scope and objectives + Capitalizes on opportunities to improve project efficiency, results or team performance and proactively takes action + Leverages information from previous projects or other client work to efficiently complete assigned project activities as well as facilitate business decisions + Produces quality work that meets the expectations of RS and the client.
Parexel
Olympia, WA
We offer: + **Meaningful Impact:** Contribute to therapies that change patients' lives + **Professional Growth:** Expand your expertise across therapeutic areas and drug development phases + **Collaborative Culture:** Work with world-class medical and scientific professionals + **Flexibility:** Remote work arrangement with work-life balance + **Innovation:** Access to cutting-edge clinical research and medical technologies **Ready to Make a Difference?** As a medical expert and strategic partner, you'll play a pivotal role in advancing therapeutic innovations while building meaningful relationships with pharmaceutical sponsors and contributing to life-changing treatments for patients worldwide.
Parexel
Olympia, WA
As a **Medical Director** at Parexel, you will provide medical monitoring for assigned projects, function as medical representative on the project team, provide medical consultation as required or requested to client/sponsor or to other Parexel service groups, and assume the role of Senior Technical Lead in selected circumstances. + Provide support for the preparation of clinical protocols, integrated clinical and statistical summary reports, journal articles, and other documents for clients/sponsors or in conjunction with clients/sponsors and in conjunction with other Parexel divisions.
Parexel
Olympia, WA
The Manager, Data Analysis, is responsible for overseeing centralized monitoring activities for global and/or complex clinical trials, ensuring the effective configuration, execution, and maintenance of Risk-Based Quality Management (RBQM) systems. Additionally, the Manager will oversee multiple studies within a designated therapy area, lead process improvement initiatives, and contribute to innovation in central monitoring capabilities through collaboration with cross-functional teams and industry partners.
Parexel
Olympia, WA
Parexel has upcoming future opportunities at the Project Leader (PM) and Senior Project Leader (SPM) level for candidates with experience leading global studies in a variety of therapeutics including Oncology (Hematology), Respiratory / General Medicine and Obesity/Endocrine** Individuals selected for these roles will provide leadership to project teams and manage the day-to-day operations while striving to achieve operational excellence through on time delivery within budget and to the highest quality with the goal to exceed client expectations Successful candidates possess an undergraduate degree in a clinical or health related field: advanced degree preferred, along with at minimum, 2+ years' experience leading Global Clinal Trials in Project Management within a CRO (preferred), Biotech or Pharma company. As a part of the Global Project Leadership organization, your work has a direct impact on the projects, teams, and clients you work with, while helping deliver projects to the benefit of the patients we serve.
Parexel
Olympia, WA
A background in clinical aspects of drug development, including all aspects of Medical Monitoring and study design/execution, preferred + Clinical practice experience + Good knowledge of the drug development process including drug safety, preferred + Experience in Pharmaceutical Medicine, preferred + Experience leading, mentoring and managing individuals/ a team, preferred **Education** + US Board certified in **Ophthalmology** + Experience as a Physician in Industry or as a clinical trial investigator is required + Previous CRO experience is strongly preferred + Medically qualified in an acknowledged medical school with completion of at least basic training in clinical medicine (residency, internship) The ability to travel 15% domestically or internationally is required. **Medical Expertise** and experience in **Ophthalmology** is essential to the medical monitor role and will be manifested in high quality consultation on protocol development or drug development programs, medical review of various documents, collaboration on internal therapeutic area meetings, training module development, white papers, slide sets, publications etc.
Parexel
Olympia, WA
Follows quality issue processes by escalating systematic or serious quality issues, data privacy breaches, Clinical Study Protocol (CSP) or ICH-GCP compliance issues to Local Management and/or Clinical Quality Management (CQM) as required. The SrCRA is responsible for the preparation, initiation, monitoring, and closure of assigned sites in clinical studies, in compliance with Client Procedural Documents, international guidelines such as ICHGCP, and relevant local regulations and that the sites deliver according to their respective commitment in the individual studies.
Parexel
Olympia, WA
Parexel FSP is looking for a CRA/Sr CRA in the MidWest and West region of the United States!** **Oncology Experience required.** **Job Purpose:** The Clinical Research Associate (CRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local study team(s). + Follows quality issue processes by escalating systematic or serious quality issues, data privacy breaches, Clinical Study Protocol (CSP) or ICH-GCP compliance issues to Local Management and/or Clinical Quality Management (CQM) as required.
Parexel
Olympia, WA
Duties may include: + Preparing network meta-analysis protocols + Reviewing data extracted from systematic literature reviews + Conducting feasibility assessments + Generating network diagrams + Critically assessing study heterogeneity + Conducting network meta-analysis + Assisting with interpretation and dissemination of findings The candidate is also expected to support **thought leadership and innovation objectives** in advanced analytics, including but not limited to: + Pairwise meta-analysis + Mixed treatment comparison + Indirect treatment comparison + Network meta-analysis + Match-adjusted indirect treatment analysis + Meta-regression + Single-arm trial analysis + Simulated treatment comparison + Surrogate outcome assessment **Skills & Qualifications** + **Master's or Doctoral-level degree** in applied statistics, health economics, or related quantitative fields. The ideal candidate will have key experience in** **NMA/Evidence Synthesis, Survival analysis, and HTA experience.** **Location: US -** Remote | **Employment Type:** Full-Time **Job Purpose** The Statistician, **Consultant, Advanced Analytics: Meta-Analysis,** contributes statistical capabilities and methodological leadership at all stages of projects, from planning to completion.
Parexel
Olympia, WA
Follows quality issue processes by escalating systematic or serious quality issues, data privacy breaches, Clinical Study Protocol (CSP) or ICH-GCP compliance issues to Local Management and/or Clinical Quality Management (CQM) as required. The CRA is responsible for the preparation, initiation, monitoring, and closure of assigned sites in clinical studies, in compliance with Client Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations and that the sites deliver according to their respective commitment in the individual studies.
Parexel
Olympia, WA
As a Biomarker Consent Specialist, you'll be joining a fast-paced, driven environment that's helping to make life-changing differences to patients by negotiating, authoring, and reviewing genetic and biomarker language in clinical trial informed consents. **Job Title:** Biomarker Consent Specialist At Parexel, we are a leading Clinical Research Organization (CRO) company specializing in delivering life- changing medicines to patients.
Parexel
Olympia, WA
Follows quality issue processes by escalating systematic or serious quality issues, data privacy breaches, Clinical Study Protocol (CSP) or ICH-GCP compliance issues to Local Management and/or Clinical Quality Management (CQM) as required. The CRA is responsible for the preparation, initiation, monitoring, and closure of assigned sites in clinical studies, in compliance with Client Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations and that the sites deliver according to their respective commitment in the individual studies.
Parexel
Olympia, WA
Technical** + Directs, leads and provides guidance to the teams in all aspects of Safety Project Leadership + Provide expertise in Safety Project Leadership and project management best practices **Quality and Compliance** + Strive to ensure internal and external clients receive the required deliverables within stipulated timelines and budget + Ensure projects assigned to line reports are completed with quality, according to SOPs, and regulatory guidelines **Skills:** + Excellent leadership and line management skills + Excellent knowledge of drug safety and the drug development process + Excellent knowledge of and ability to interpret and apply global safety regulations + Experience in data analysis, evaluation of safety data and the preparation of safety reports preferred + Excellent team / project leadership and delegation skills + Ability to train and mentor people + Excellent presentation skills + Excellent interpersonal skills + Excellent time management skills + Client focused approach to work + Experience with Pharmacovigilance related computing systems + Clinical Research or Pharmacovigilance knowledge /qualifications + Computer proficiency, ability to work with web-based applications and familiarity with the Windows operating system and Microsoft Office apps + Ability to comprehend various regulatory or client requests and be able to strategize a handling approach + Flexible attitude with respect to work assignments and new learnings + Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail + Willingness to work in a matrix environment and to value the importance of teamwork **Knowledge and Experience** : + Minimum 13+ years of pharmaceutical and/or CRO experience including but not limited to areas of focus in clinical operations, sales and decentralized clinical trials/direct to patient studies + 7-10 years of management experience, including direct project management or program oversight **Education:** + Requires BA/BS degree or equivalent combination of education and experience or equivalent related degree and/or experience, plus significant executive and/or senior management experience, preferably in worldwide clinical research, pharmaceutical, or biotechnology company. You will lead operational level planning with significant business oversight, drive 'positive change' throughout Parexel through continuous process improvement programs, as well as make significant contributions to the leadership of the Business Unit (BU) and the development of the strategy and direction of the BU.
Parexel
Olympia, WA
Follows quality issue processes by escalating systematic or serious quality issues, data privacy breaches, Clinical Study Protocol (CSP) or ICH-GCP compliance issues to Local Management and/or Clinical Quality Management (CQM) as required. The SrCRA is responsible for the preparation, initiation, monitoring, and closure of assigned sites in clinical studies, in compliance with Client Procedural Documents, international guidelines such as ICHGCP, and relevant local regulations and that the sites deliver according to their respective commitment in the individual studies.
Parexel
Olympia, WA
For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is trusted by life sciences companies to meet their long-term staffing needs for scientists and engineers and related professionals in discovery and development of novel therapies, keeping patients at the center of everything we do, and where an inclusive community helps you be your best, transforming any career into a life-changing achievement. We provide pharmaceutical and biopharmaceutical companies with qualified and talented technical professionals to support the development and delivery of new therapies.
Parexel
Olympia, WA
Location** : United States - Remote **Key Accountabilities** : **Operational Execution** + Provide broad statistical support, including trial design, protocol and CRF development on specific studies + Lead production and quality control of randomization, analysis plans, statistical reports, statistical sections of integrated clinical reports and other process supporting documents + Perform sample-size calculations, generate randomization lists and write statistical methodology sections for inclusion in study protocols + Provide statistical input into Data Monitoring Committee (DMC) activities, including development of DMC charters and analysis plans + Provide a supporting role as a non-voting independent statistician providing data and analysis for DMC review **Business Development** + Support of Business Development, by actively contributing to study design considerations in internal and client meetings, providing and discussing sample size scenarios, support of budget and proposal development, attending and preparing bid defense meetings **General Activities** + Understand regulatory requirements related to the specific therapeutic areas and the implications for statistical processing and analysis + Understand, apply and provide training in extremely advanced and sometimes novel statistical methods + Contribute to the development and delivery of internal and external statistical training seminars and courses + Review position papers based on current good statistical practice + Interact with clients and regulatory authorities + Review publications and clinical study reports + Travel to, attend, and actively contribute to all kind of client meetings as appropriate (e.g. The Principal Biostatistician works independently on all level complexity clinical trial projects, often with major regulatory impact.
Parexel
Olympia, WA
Lead intake and prioritization discussions for all Clinical Operations technology requests, in coordination with PMO/Portfolio teams + Ensure Clinical Operations-related initiatives align with broader D&T strategy, organizational restructuring decisions, and operational goals. **Job Title** : Executive Director, Data & Technology Clinical Operations **Job Introduction** : The **Executive Director, D&T Clinical Operations** leads all technology, data, and operational enablement functions supporting Parexel's Clinical Operations organization.
Parexel
Olympia, WA
This role is responsible for accelerating AI adoption across clinical, operational, and corporate functions; operationalizing safe and compliant AI systems; co-leading governance frameworks; and scaling platforms, capabilities, and talent that enable Parexel to leverage AI for efficiency, quality, and innovation. The VP partners extensively with senior executives, including Clinical, Safety, Corporate Functions, D&T, Quality & Compliance, and operational delivery units, ensuring that AI capabilities align with business priorities and comply with regulatory expectations for the life sciences sector.
Parexel
Olympia, WA
Use innovative technology to improve effectiveness and efficiency of the business + Partner with business leaders to ensure systems availability and support: + Feasibility modeling + Country and site selection + Document collection and workflows + ICF customization + EC/RA/MoH submissions + SIV scheduling and activation readiness **Enablement of Feasibility, Site Identification & Country Strategy** + Provide technology, analytical models, and data tools for feasibility assessments, including site intelligence, enrollment scenario modeling, and country strategy inputs + Ensure real-time access to feasibility insights, performance history, and site data across data platforms. + Ensure end-to-end system readiness and integration for: + Regulatory document management + Site regulatory package preparation + Greenlight/activation processes + System setup and training workflows **Operational Reporting, Data Quality & Predictive Insights** + Build and scale reporting capabilities that measure startup progress, activation risks, feasibility metrics, and regulatory timelines.
Parexel
Olympia, WA
This role also contributes to site selection, provides local intelligence, ensures site support, resolves issues, and collaborates with various functions to optimize communication, maintain site quality and patient safety utilizing data analytics to identify and mitigate risks. The Site Care Partner is a crucial liaison for investigative sites throughout a study's lifecycle, responsible for site start-up, activation, relationship management, recruitment, and quality assurance.
Parexel
Olympia, WA
Providing medical inputs to case processing team + Raising appropriate follow-up queries for relevant information from the reporter/HCP (Health Care Professional) + Review and verify appropriate selection of adverse events from source documents, assign appropriate Medical Dictionary for Regulatory Activities (MedDRA) code, review narrative + Identify and resolve case issues, coordinate with client therapeutic/legal team + Provide guidance to junior physicians on case assessment methodologies **Periodic reports (as applicable)** + Reviewing and/ or authoring of aggregate reports for medical content and consistency in accordance with client requirements and SOPs + Providing medical inputs into, and supporting the preparation of key regulatory documents including but not limited to, Periodic Benefit-Risk Evaluation Reports (PBRERs)/ Periodic Safety Update Reports (PSURs), Signal Evaluation Reports (SERs), Health Authority (HA) response documents, Development Safety Update Reports (DSURs), Clinical Overviews (COs), Addendum to Clinical Overview (ACOs), Health Hazard Evaluation reports (HHEs), etc. **Key Accountabilities:** **General** + Maintaining a good working knowledge of the Adverse event/Safety profile of assigned products, labeling documents, data handling conventions, client's guidelines and procedures, and global drug safety regulations and guidelines + Maintaining an awareness of global regulatory requirements, reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for adverse event reporting + Communicating and discussing issues related to review process with Line Manager/ Project Leader/Designee + Interacting with internal and external stakeholders for resolving issues + Attending and/ or presenting at client/cross functional meetings along with other stakeholders.
Parexel
Olympia, WA
Work in partnership with and/or escalate to the SCP to ensure quality of site delivery + Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites + Partner with Site Care Partner to perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients; provide protocol training to, and address protocol related questions from the investigator site staff when required, including discussions on known/anticipated operational and clinical trial risks + Attend investigator meeting when required (virtual or F2F). CRA is responsible for the resolution of all protocol-related issues for assigned investigator sites and will work closely with the Site Care Partner (SCP), and other members of the study team, as required, in activities associated with the set-up, running and close-out of sites in a clinical trial.
Parexel
Olympia, WA
Exceptional opportunity for a highly experienced analytical chemist to partner with a large global biopharmaceutical client and lead regulatory CMC strategy for cutting-edge peptide and oligonucleotide therapeutics. **Qualifications & Experience** + **Educational Background** + Bachelor's or Master's degree in chemistry, biochemistry, pharmaceutical sciences, or related discipline.
Parexel
Olympia, WA
Thorough understanding of scientific principals and regulatory systems, relevant to drug development + Experience writing CCDS and local labeling documents for new products **Knowledge and Skills** + Solid understanding and practical knowledge of labeling regulatory requirements, regulations and guidance required + Solid understanding of implications of global labeling across the organization and globally + Solid understanding of the structure of product labeling + Experience in effectively/appropriately prioritizing and managing multiple high to medium complex projects simultaneously + Ability to work independently or in teams, globally. + Effective written and oral communication and organizational skills + Strong attention to detail + Solid aptitude for use of IT systems; preferable knowledge with Regulatory Information Management System (RIMS) and electronic document management system (EDMS); Proficiency in MS Office suite; Willing to learn additional applications + Ability to think strategically, communicate risks, and recommend innovative solutions to problem solving + Ability to recognize and escalate issues + The ideal candidate should be action-oriented, customer focused, ability to manage workloads and set priorities.
Parexel
Olympia, WA
Participate actively in study planning with feasibility leaders, solution consultants + Participate in team project and investigator meetings + Provide training of study teams on TA indication and protocol ( _Note that this does not include any direct medical advice on patient care or management)_ + Communicate with relevant sponsor counterparts on challenges and accomplishments related to assigned project/study + Participate in the development and/or review of study documents, such as clinical protocols, Medical Monitoring Plans (MMP), integrated clinical and statistical summary reports, safety plans, Informed Consent Forms, etc. in conjunction with clients/sponsors or in conjunction with other Parexel departments + Deliver medical monitoring activities according to MMP during the study conduct: + Answer to site/ study team questions relating to the study conduct or protocol, + Review and sign off all data listings / tables, protocol deviations, datasets, for medical accuracy/consistency in accordance with study plans (Medical Monitoring Plan, Medical Data Review Plan, Data Surveillance Plan etc.) + Deliver medical leadership to the project in close coordination with the Project Leader and according to the role assigned either GLP or RLP by + Timely identifying risks and challenges, + Pro-actively proposing and/or delivering relevant actions contributing to the success of the study/project and risk mitigation. + Support patient centricity, diversity and inclusion in all projects **Departmental and Team Leadership, where applicable:** + Participate as requested in internal initiatives aiming at improving Parexel and GMS operational model + Contribute to the development of departmental capabilities including procedures and technology + Actively work with Section Heads to ensure development and performance of self and team + Create a culture of continuous improvement and lead team through change to deliver desired outcomes + Support timely assignment of MD to proposals, projects and studies + Manage the team members according to Parexel tools, guidelines and procedures + Guide, energize, motivate and coach team members to perform at the top of their abilities, in line with Parexel values and their organizational and personal career goals + Support talent development of team and create environment and opportunities for each team member to thrive + Mentor/Manage team through clear and specific definition of accountabilities and expectations, assigning task/projects based on competencies and skills and helping staff to prioritize workload: + to maintain adequate billability rate and efficient ratio between workload and personal life according to local guidelines + to provide efficient support to BD activities including request for proposals, participation in bid pursuit meetings, capability meetings etc.
Parexel
$60000 - $70000
Olympia, WA
As they progress through the program, APEX CRAs perform billable project tasks to support the CRAs and Clinical Operations Leads (COLs) with a focus in three developmental areas: Project Support, Initiation CRA support, and Site Facing support. The actual salary offered may vary within the range based on a number of factors including position/level offered, skills, education, training, experience, professional achievement, and location._ _Some roles may also be eligible for additional incentives, bonuses, and other benefits.
Parexel
Olympia, WA
Experience in analyzing biologics including monoclonal antibodies and/or other therapeutic proteins using at least one of the following techniques: + Liquid Chromatography (HPLC / UPLC) + Protein A Titer, Size Exclusion Chromatography (SEC), Ion Exchange Chromatography (IEX, AEX, CEX), Reverse Phase (RP), or Hydrophobic interaction chromatography (HIC) + Electrophoretic methods such as capillary electrophoresis sodium dodecyl sulfate (CE-SDS) and/or capillary isoelectric focusing (cIEF) + ELISA (HCP, proA) and binding potency assay + qPCR and basic molecular biology techniques (gel electrophoresis, etc.) + High-throughput liquid handling system, e.g., Tecan, Bravo, etc. + Basic instrumentation troubleshooting + **Ability and willingness to train in molecular biology and immunoassay testing** + **Familiarity with Microsoft Office Applications (Outlook, Excel, Word, PowerPoint, OneNote, Teams, etc.)** **Desired Skills and Experience** + Familiarity with compendial testing such as UV 280, pH, and Physical Observations + **Ability to follow complicated scientific protocols / procedures** + Making accurate reagent preparations (dilutions / solutions / buffers / mobile phases) + Good documentation practices & utilization in electronic lab notebooks (ELN) + Analytical software such as Empower.