Global Clinical Operations Leader / Clinical Trial Manager Parexel International CorpGlobal Clinical Operations Leader / Clinical Trial ManagerRaleigh, NCRemoteWith more than 22,000 employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient focused clinical trials that broaden access and make research a care option for anyone anywhere. You will serve as the primary clinical liaison to project leadership and sponsor teams coordinating cross functional contributors across regions and time zones.
Scientist III - Peptide Synthesis Discovery Chemistry - FSP Parexel International CorpScientist III - Peptide Synthesis Discovery Chemistry - FSPNJFor 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. Under direction and guidance of the scientific supervisor or more senior group members: Execute any aspects (synthesis, workup, purification, analysis) of routine peptide preparations in a range of scales and demonstrate flexibility and rapid pace in moving across this space.
Account Strategy Director Parexel International CorpAccount Strategy DirectorNCLead and coordinate RFP response processes from the sales perspective, partnering with Account Executives, bid defense teams, subject matter experts, and operational teams to develop winning strategies and ensure high-quality, competitive, and timely submissions. Responsibilities include leading proposal strategies, developing customer intelligence, coordinating break-in strategies, and supporting business development initiatives, with opportunities to deepen your expertise and influence account outcomes.
Scientist III - Peptide Synthesis Discovery Chemistry - FSP Parexel International CorpScientist III - Peptide Synthesis Discovery Chemistry - FSPNJFor 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. Under direction and guidance of the scientific supervisor or more senior group members: Execute any aspects (synthesis, workup, purification, analysis) of routine peptide preparations in a range of scales and demonstrate flexibility and rapid pace in moving across this space.
Scientist III - Potency Assay - FSP Parexel International CorpScientist III - Potency Assay - FSPNJFor 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. Analysis of biologics including monoclonal antibodies and/or other therapeutic proteins in one or more of the following techniques: Enzyme-linked immunosorbent assay (ELISA), host cell proteins (HCP), protein-A proA), and binding potency assay.
Scientist III - Potency Assay - FSP Parexel International CorpScientist III - Potency Assay - FSPNJFor 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. Analysis of biologics including monoclonal antibodies and/or other therapeutic proteins in one or more of the following techniques: Enzyme-linked immunosorbent assay (ELISA), host cell proteins (HCP), protein-A proA), and binding potency assay.
Clinical Trial Leader - FSP Parexel International CorpClinical Trial Leader - FSPNCThe CTL provides leadership and direction to the trial team (core and extended team members) and is accountable for the overall success and delivery of their assigned clinical trial according to defined milestones and key performance indicators. CTLs are accountable for the set-up, execution and delivery of their assigned trial(s) and contribute to delivery of client's pipeline through accurate planning and efficient execution of trials that bring speed and value to participating subjects and sites.
Scientist III - Analytical Chemist - FSP Parexel International CorpScientist III - Analytical Chemist - FSPNJFor 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 are looking to fill a Scientist III - Analytical Chemist position working as a full-time employee of Parexel FSP on long-term assignment onsite at one of our clients located in Rahway, NJ.
Project Leadership - Biotech (clinical trials) -Dermatology - Home Based - (Future Needs) Parexel International CorpProject Leadership - Biotech (clinical trials) -Dermatology - Home Based - (Future Needs)NCSuccessful 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. 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.
Site Activation Leader (West Coast Remote) Parexel International CorpSite Activation Leader (West Coast Remote)CORemoteYou will play a critical role in accelerating clinical research by driving efficient site start-up activities from feasibility through activation across multiple studies and therapeutic areas. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Project Leadership - Biotech (clinical trials) - Oncology - Home Based - (Future Needs) Parexel International CorpProject Leadership - Biotech (clinical trials) - Oncology - Home Based - (Future Needs)NCSuccessful 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. 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.
R0000030967 Senior / Vice President, Technical - Clinical Regulatory Affairs (home-based) Parexel International CorpR0000030967 Senior / Vice President, Technical - Clinical Regulatory Affairs (home-based)MDWe're currently seeking a highly experienced Clinical Regulatory Leader, Health Authority Medical Review Team Lead, Master/Senior Medical Review Officer who is looking to draw upon their wealth of experience in clinical trial design and drug development to join Parexel's highly recognized Regulatory Strategy team! Minimum Work Experience - 15+ years experience with expert level industry or regulatory knowledge experience in Clinical Development/Clinical Trial Design, Clinical Strategy, and authoring clinical sections of regulatory applications.
Project Leadership - Mid/Large- (clinical trials) - Homebased - (future needs) Parexel International CorpProject Leadership - Mid/Large- (clinical trials) - Homebased - (future needs)NCThe Global Project Leadership department has dedicated members at all levels who are aligned to work with specific types of clients and deliver solutions customized to fit those client's needs, working on projects spanning across all phases of global clinical trials, in a wide array of therapeutic areas. Parexel has upcoming opportunities in a variety of therapeutics at the Project Leader (PM) and Senior Project Leader (SPM) level for candidates with experience leading global studies in a variety of therapeutics supporting mid to large size biotech/ pharma clients.
Financial Analyst III Parexel International CorpFinancial Analyst IIIRaleigh, NCWhat you'll do: Create accurate, transparent, and timely financial analysis to support project leadership in project decision making process; clearly articulate financial implications of business decisions and provide retrospective analysis as well as drive forward looking actions on simpler projects / contract types. Provide updates on financial status for assigned projects and create information in response to any client financial reporting needs for assigned projects in the area of project reporting, forecasting, or transactional details for the projects within the portfolio.
Local Study Associate Director- FSP Parexel International CorpLocal Study Associate Director- FSPNCRemoteThe Local Study Associate Director (LSAD) leads Local Study Team(s) (LSTs) at country level to deliver committed components of clinical studies according to agreed resources, budget and timelines complying with Client Procedural Documents, international guidelines such as ICH-GCP as well as relevant local regulations. Ensures all country and site level trial essential documents required by ICH-GCP prior to study start have been collected and verified for correctness, prior to setting sites ready to enroll, and in line with Client SOPs.
Senior Patient Safety Project Lead Parexel International CorpSenior Patient Safety Project LeadNCWith diverse teams and continuous learning opportunities, the Senior Patient Safety Project Lead can expand expertise across pharmacovigilance, project leadership, and strategic partnership management while helping shape the future of clinical research. With 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient focused clinical trials that broaden access and make research a care option for anyone, anywhere.
Site Care Partner - FSP Parexel International CorpSite Care Partner - FSPPAConducts study start up activities at the site level including but not limited to PTA, coordination of site activation checklist items, Informed Consent Document (ICD) finalization, Site Initiation Visit (SIV), as applicable, including management of issues that may compromise time to site activation. Coordinates with other roles and functions that interface with study sites (e.g., Study Monitor, Investigator Contracts Lead, Site Activation Partner, Clinician, etc.) optimizing communications and enhancing overall visibility into and confidence of quality of site level activities.
Site Care Partner - US, Any Region - FSP Parexel International CorpSite Care Partner - US, Any Region - FSPVAConducts study start-up activities at the site level including but not limited to Site Qualification, coordination of site activation checklist items, Informed Consent Form (ICF) finalization, Site Initiation Visit (SIV) as applicable, including management of issues that may compromise time to site activation. 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.
Patient Safety Associate I (Drug Safety Associate I) Parexel International CorpPatient Safety Associate I (Drug Safety Associate I)NCWith 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient focused clinical trials that broaden access and make research a care option for anyone, anywhere. As a Patient Safety Associate I, you will contribute to a broad range of safety operations, including individual case safety report processing, safety submissions, literature review activities, affiliate support, regulatory support, and regulatory intelligence activities.
Data Manager Lead / Data Manager II Parexel International CorpData Manager Lead / Data Manager IINCThe successful candidate will manage study data delivery timelines, including Go-Live, Interim Deliveries, and Final Database Lock, while working with minimal guidance from Line Managers and/or Subject Matter Experts. This role is responsible for ensuring contracted Data Management deliverables are met with a focus on quality and timeliness, while collaborating closely with cross-functional teams across global geographies.