Promote good clinical practices in the conduct of clinical investigations by possessing an in-depth knowledge of federal regulations and K2 Medical Research guidelines (SOPs) for the enrollment and maintenance of subjects in clinical trials, and by collecting, recording, and maintaining source and sponsor documentation. Job DescriptionJob Description
At K2 Medical Research, we are transforming healthcare by delivering tomorrow’s treatments today.
The ideal candidate will oversee cross-functional teams, manage collaborations with external partners (CROs, academic institutions, and biotech companies), and ensure timely and compliant execution of preclinical projects that support early therapeutic development. NoLicenses and CredentialsExperienceResearch Related Experience 5-7 years required and Supervisory Experience 1-2 years preferredKnowledge, Skills and Abilities- Ability to make independent effective decisions.-
Our diligent team of recruiters and client representatives specialize in permanent placement and locum tenens opportunities in all settings of medical practice such as hospitals, outpatient clinics, home health care, and government facilities. Provider Healthcare is a prominent healthcare recruitment firm that places highly qualified and skilled healthcare professionals in excellent employment opportunities across the country.
Boston, Massachusetts30 days ago
Learn more about Beacon Hill and our specialty divisions, Beacon Hill Associates, Beacon Hill Financial, Beacon Hill HR, Beacon Hill Legal, Beacon Hill Life Sciences and Beacon Hill Technologies by visiting www.bhsg.com. Our client, a life sciences services company, is seeking an Operations Support Specialist to provide onsite administrative and operational support within a large, well-established research environment in Boston.
p>As the Senior Manager, Clinical Operations- GI at Iterative Health you will serve as a strategic advisor to sponsors, CROs, and research sites, translating operational challenges into scalable solutions that improve study execution, accelerate activation timelines, and drive patient recruitment performance. We built a leading performance-driven network of 100+ sites across the US, Europe, India, and Australia, conducting research directly in the communities where care is delivered across gastrointestinal, hepatology, obesity, and cardiology.
div class="content-pay-transparency">New York pay range
$140,000—$165,000 USD
At Iterative Health, we're actively working towards creating an environment that is representative of the diversity of patients our technology serves.
As the Senior Manager, Clinical Operations- GI at Iterative Health you will serve as a strategic advisor to sponsors, CROs, and research sites, translating operational challenges into scalable solutions that improve study execution, accelerate activation timelines, and drive patient recruitment performance.
p>As the Senior Manager, Clinical Operations- Cardiology at Iterative Health you will serve as a strategic advisor to sponsors, CROs, and research sites, translating operational challenges into scalable solutions that improve study execution, accelerate activation timelines, and drive patient recruitment performance. By combining deep clinical research expertise with a consultative approach, this individual will help strengthen sponsor relationships, elevate site performance across the network, and contribute directly to Iterative Health''s mission of bringing innovative therapies to patients faster.
Aktis' most-advanced program, AKY-1189, is a miniprotein radioconjugate targeting Nectin-4, with multi-indication potential across multiple tumor types, including locally advanced or metastatic urothelial cancer, breast cancer, non-small cell lung cancer, colorectal cancer, cervical cancer, and head and neck cancer. Aktis Oncology, Inc. is a clinical-stage oncology company focused on expanding the breakthrough potential of targeted radiopharmaceuticals to large patient populations, including those not addressed by existing platform technologies.
Cambridge, MA30+ days ago
p>The Vice President, Business Operations & Partnerships is a critical executive-level role responsible for defining, governing, and scaling the operating model that enables Alnylam's Pipeline Delivery organization to execute on clinical trials with speed, quality, and predictability across a growing and increasingly complex portfolio. Vendor & Alliance Management: Define and execute a forward-looking, centralized vendor strategy, ensuring strong governance, clear accountability, and high-performing partnerships that enable speed, quality, and cost efficiency while keeping an enterprise lens.
div class="content-pay-transparency">New York pay range
$140,000—$165,000 USD
At Iterative Health, we're actively working towards creating an environment that is representative of the diversity of patients our technology serves. By combining deep clinical research expertise with a consultative approach, this individual will help strengthen sponsor relationships, elevate site performance across the network, and contribute directly to Iterative Health's mission of bringing innovative therapies to patients faster.
p>The Clinical Trial Associate (CTA) provides clinical trial coordination support to Project Teams for assigned clinical trial(s).This support includes tracking a wide range of key operational activities and maintenance of essential study documentation, including the electronic Trial Master File (eTMF). We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.
If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.
Boston, Massachusetts23 days ago
FICERA specifically addresses a key challenge in solid tumor treatment by enabling immune cell penetration into tumors, reducing fibrosis and immunosuppression while reversing TGF--driven resistance mechanisms - ultimately designed to drive the deep, durable responses that may translate into better outcomes and survival for patients. Ability to work independently and successfully in a fast-paced, results-driven, highly accountable environment with large potential impact; ability to prioritize and manage multiple tasks simultaneously, integrate cross-functional issues, and balance competing priorities effectively.
The ideal candidate brings deep oncology experience, strong global study oversight, and the ability to influence stakeholders, anticipate challenges, and deliver results in a dynamic biotech environment. Frontier Medicines is seeking an experienced Clinical Operations team member to drive the operational strategy and execution of a global oncology program as it advances through clinical development.
Cambridge, MA30+ days ago
Responsible for review and oversight of the study-level budget(s) and demonstrates accountability for the management of the budgets through managing the review and approval of contracts and/or work order changes; contribute to budget forecasting and accruals in collaboration with finance. The targeted salary range below reflects what Nuvalent reasonably and in good faith expects to offer for this position at the time of posting, but the final salary determination may be within or outside this range based on various factors, including, but not limited to, experience, skills, education, and market factors.
The Global Head of Clinical Operations oversees global clinical operations capabilities, drives innovation and trial design and execution, and ensures inspection readiness and regulatory compliance across all regions. Drive continuous improvement of clinical operations through the implementation of innovative approaches, including risk-based quality management (RBMQ), centralized monitoring, and data-driven decision-making.
div>By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use.
Oversight of Strategic Partners/CRO/vendor selection, budget and contract negotiation, and proper supervision of performance for all activities assigned to a Strategic Partner/CRO/vendor for assigned program(s), including escalation of issues to and participation in governance committees; accountable for operational risk management strategy in collaboration with Strategic Partners.
p>Role Summary: The Clinical Operations (Program) Lead is the clinical operations functional representative at the Program team, is responsible for developing and leading the strategy, planning, oversight, implementation and delivery of program and study level clinical operations deliverables as outlined in the clinical development plan (CDP).
Takes overall accountability for operational delivery of the clinical studies within a Program and provide appropriate oversight to ensure a high quality, ethical, cost efficient way to meet timelines and patient recruitment goals.
Boston, Massachusetts30+ days ago
The Global Head of Clinical Operations oversees global clinical operations capabilities, drives innovation and trial design and execution, and ensures inspection readiness and regulatory compliance across all regions. Drive continuous improvement of clinical operations through the implementation of innovative approaches, including risk-based quality management (RBMQ), centralized monitoring, and data-driven decision-making.
As a key member of the Breast and Skeletal Health BSH Clinical Affairs team, the Clinical Operations Quality Manager will oversee and execute major US-based and global clinical trials across multiple phases of product development with a strong focus on quality oversight and quality assurance. This role requires close collaboration with global regional teams and cross-functional partners including Clinical Development, R&D Program Management, Regulatory Affairs, Legal, Marketing, and Service and Operations.
p>We are seeking an expert Senior Program Manager of Clinical Research Operations to provide high-level operational, regulatory, and strategic management across multiple active research projects. With the pay range(s) shown above, the starting salary will depend on several factors, which may include your education, experience, location, knowledge and expertise, and skills as well as a pay comparison to similarly-situated employees already in the role.
Cambridge, MA30+ days ago
p>The Associate Director, Clinical Operations Program Lead, Study Start-up and Feasibility will report to the Director, Patient Recruitment and Start-Up Strategy and will lead a team to drive the strategy and implementation of country and site feasibility for our studies and support the internalization of country and site feasibility. The Associate Director, Clinical Operations Program Lead, Study Start-up and Feasibility will report to the Director, Patient Recruitment and Start-Up Strategy and lead a team to drive the strategy and implementation of feasibility and study start-up across all clinical programs.
Watertown, MA30+ days ago
li style="color:#262626;line-height:normal;background:white">Work closely with translational medicine team to ensure appropriate incorporation of bioanalytical sampling plan into clinical protocols and relevant data output of the trial is provided to functional groups for review. Provide study-specific training and leadership to clinical research staff, CRO, CRAs, sites and other contract personnel.
Cambridge, Massachusetts14 days ago
div class="content">Summary
The Senior Director of Clinical Operations oversees all aspects of clinical trial execution, including start-up, monitoring, and close-out activities for all ARTBIO programs. The Senior Director of Clinical Operations collaborates closely with cross-functional teams, including clinical development, project management, regulatory, quality, finance, and translational and discovery research, to drive the successful execution of clinical study plans.
Drive HR governance and change leadership by ensuring HR solutions align with AstraZeneca's global HR frameworks, applying best-practice tools and techniques in organizational efficiency, change management, employee engagement, workforce transitions, and performance management. Act as a strategic HR partner to Clinical Operations executives and cross-functional leaders, designing and delivering tailored HR solutions with clear scopes, timelines, budgets, and measurable outcomes that support critical programs and projects.
ul>Inclusion and Belonging- Committed to Welcoming, Celebrating and Thriving on Inclusion and Belonging, Learn more about Employee Inclusion Groups on our website (https://www.smith-nephew.com/). Join us as a Senior Specialist Clinical Operations and play a critical role in leading clinical trial contracting and budget negotiations that directly support the development of innovative medical technologies.
For more information about our science, pipeline and people, please visit www.kymeratx.com or follow us on X (formerly Twitter) or LinkedIn. Having advanced the first degrader into the clinic for immunological diseases, Kymera is focused on building an industry-leading pipeline of oral small molecule degraders to provide a new generation of convenient, highly effective therapies for patients with these conditions.
Cambridge, Massachusetts18 days ago
ul>Program Oversight: Clinical operations leadership across assigned programs, including trial management, site monitoring, vendor selection and oversight, TMF, data operations, timeline and budget adherence. Team Leadership: Provide line management, coaching, and mentorship to assigned team members, as well as represent clin ops in various cross functional forums (Program team, sub-teams, etc).
li>Lead operational oversight of CROs, technology vendors, recruitment partners, and other external service providers, establishing scalable governance frameworks, performance metrics, and escalation pathways to ensure high-quality delivery and accountability. Oversee Clinical Data Management and clinical trial technologies, ensuring high-quality, timely, and compliant data collection, management, and delivery across systems including EDC, CTMS, eConsent, ePRO, eTMF, and remote study platforms.
Cambridge, MA30+ days ago
The Director, Clinical Operations Program Leadership (COPL) is responsible for leading the strategy, planning and implementation of clinical development program operations in the Clinical Trial Delivery Unit of the Quantitative Science Development Operations organization (QSDO). Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.
Needham, Massachusetts30+ days ago
p>This role is ideal for someone who thrives in a fast-paced biotech environment, can independently lead complex global studies, proactively solve problems, and confidently navigate ambiguity while remaining hands-on and team-oriented. We’re looking for an Associate Director, Clinical Operations to lead execution of global oncology clinical studies with strategic oversight, operational excellence, and a collaborative leadership style.
Boston, Massachusetts5 days ago
div>Provide day-to-day support and maintenance for business-critical applications such as Veeva Vault Clinical Trial Management System (CTMS), Veeva Electronic Trial Master File (eTMF), and Elluminate Electronic Data Capture (EDC) platform, ensuring maximum uptime, high performance, and excellent customer service .
At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations.
Cambridge, MA30+ days ago
Designed to make only the right edit at the right position within a gene while minimizing unwanted DNA modifications, Prime Editors have the potential to repair almost all types of genetic mutations and work in many different tissues, organs and cell types. The Company is leveraging its proprietary Prime Editing platform, a versatile, precise and efficient gene editing technology, to develop a new class of differentiated, one-time, potentially curative genetic therapies.
As Senior Clinical Operations Lead, you will hold strategic accountability for highly complex assets spanning multiple indications covering - including large Phase III global outcomes trials, rare disease programmes and co-development partnerships - across therapeutic areas including hepatology, renal and cardiovascular disease. Significant senior clinical operations leadership experience in a pharmaceutical or CRO environment, with a track record of delivering highly complex, multi-asset programmes across therapeutic areas including hepatology, renal and cardiovascular diseases.
div>By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.
Cambridge, MA30+ days ago
p>Participates in reviews and provides direction on CRO and vendor outsourcing strategy and key performance indicators (KPIs) ensuring vendor CRO partners consistently deliver high-quality data to support regulatory requirements. Strategic Thinking: General knowledge of all major aspects of drug discovery and development along with effective departmental leadership to be an effective problem solver for complex problems.
p>In a competitive external landscape and fast-paced internal environment, the Immunology Clinical Operations Lead position provides both strategic and operational leadership across early immunology programs, ensuring timely, high-quality execution of clinical studies and clinical pharmacology strategies worldwide. Translational Medicine (TMed) drives early clinical development of novel therapeutics by partnering with Discovery Sciences and Late-Stage Clinical Research to translate scientific discoveries into human proof-of-concept and advance the most promising candidates through the pipeline to patients.
Watertown, MA30+ days ago
This individual possesses clinical operations expertise with a track record of success, working with peers and stakeholders across multiple disciplines to drive programs with multiple studies and indications through all phases of clinical trials (Phase I-III). Having advanced the first degrader into the clinic for immunological diseases, Kymera is focused on building an industry-leading pipeline of oral small molecule degraders to provide a new generation of convenient, highly effective therapies for patients with these conditions.
Watertown, MA30+ days ago
This hands-on position will lead and support all aspects of clinical trial operations including planning, implementation, execution, and management of clinical studies by overseeing day-to-day operations, including direct management of outside Clinical Research Organizations (CROs) for several clinical stage oncology assets. Maintain knowledge across the clinical operations team of program specific therapeutic areas, current medical practice, and pharmaceutical regulations in order to ensure best practice across all activities and appropriate communication to study sites.
For more information about our science, pipeline and people, please visit www.kymeratx.com or follow us on X (formerly Twitter) or LinkedIn. Having advanced the first degrader into the clinic for immunological diseases, Kymera is focused on building an industry-leading pipeline of oral small molecule degraders to provide a new generation of convenient, highly effective therapies for patients with these conditions.
ul>Preference for at least one of the following fields of study: Accounting, Actuarial Science, Analytics/Data Science, Business Administration/Management, Computer Science/Information Systems, Economics, Engineering, Finance, Government/Public Policy, Health Administration/Public Health, Mathematics/Statistics, Operations/Supply Chain, Organizational Management/Behavior, Risk Management/Insurance. PwC does not intend to hire experienced or entry level job seekers who will need, now or in the future, PwC sponsorship through the H-1B lottery, except as set forth within the following policy: https://pwc.to/H-1B-Lottery-Policy.
Cambridge, Massachusetts30+ days ago
p>By submitting this application, you confirm that you've read and understood our privacy policy, which informs you how we process and safeguard your data - https://www.r-dpartners.com/privacy-policy/. - Responsible for end-to-end execution of clinical supply activities including IRT, packaging, labeling, distribution, inventory management, returns, destruction, and study closeout.
You will sit at the center of Hemabs clinical strategy and execution, owning end-to-end delivery across a growing global portfolio, from first-in-human studies to pivotal trials, while continuously finding smarter, faster, and more patient-centric ways to operate. Proactively identify and implement process innovations including novel trial designs, technology platforms, and decentralized/hybrid trial elements to accelerate timelines and improve patient access.
Accountabilities: Clinical Program Oversight: Lead end-to-end oversight of clinical program activities, advancing relevant issues to senior governance and providing clinical operations expertise in feasibility, country selection, operational input to design, risk management, and external partner management. Line Management: Provide line management to global clinical operational leaders at the study and program levels, including Global Study Associate Directors or Global Study Directors and Global Program Directors aligned to the product team's deliverables.
process SME).Essential Requirements:Relevant experience in pharmaceutical industry /biotech /CRO drug development environment with a solid understanding of drug development process, and early clinical development preferred1+ years'' experience in early phase clinical trials operations Solid knowledge of clinical trials site selection, global /country specific requirements, timelines and challenges in clinical trial execution processDesirable requirement: Successful completion of Academy fellowship programThe salary for this position is expected to range between $108,500 and $201,500 per year. Key Responsibilities:Provides operational and logistical support to clinical trials in Biomedical Research (BR) with focus on increased complexity and/or priority status, in compliance with Novartis processes and Good Clinical Practice (GCP).Perform defined activities to support the Clinical Trial Team (CTT) throughout the study lifecycle, via study assignment and/or on-demand support.
p>Pioneering Medicines, an initiative of Flagship Pioneering, is building a world-class biopharmaceutical R&D capability focused on conceiving and developing life-changing treatments for patients by harnessing the power of Flagship''s scientific platforms and applying those innovative approaches to serious diseases with unmet medical need. Flagship has been recognized twice on FORTUNE's "Change the World" list, an annual ranking of companies that have made a positive social and environmental impact through activities that are part of their core business strategies, and has been named four times to Fast Company's annual list of the World's Most Innovative Companies.
Watertown, MA30+ days ago
Having advanced the first degrader into the clinic for immunological diseases, Kymera is focused on building an industry-leading pipeline of oral small molecule degraders to provide a new generation of convenient, highly effective therapies for patients with these conditions. Work closely with translational medicine team to ensure appropriate incorporation of bioanalytical sampling plan into clinical protocols and relevant data output of the trial is provided to functional groups for review.