- Genmab (NJ)
- …in relevant technical area.Minimum requirement: 3-5 years in clinical trial operations.Experience in coordination and support activities for clinical ... would love to have you join us!The RoleAs Senior Clinical Trial Associate (Sr CTA) you play...and maintain the study TMF PlanClinical Study Report (CSR) Management: Support filing appendices of Clinical Study Report… more
- Merck & Co. (Rahway, NJ)
- …ongoing contract management. This role will report to the Associate Director, Clinical Trial Central Labs to support high quality sourcing initiatives ... negotiate and influence stakeholders and suppliers in the context of a challenging clinical trial environment.Must be adaptable in dealing with ambiguous and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and International Conference on Harmonization (ICH) guidelines. Key focus is on providing clinical trial management support to study teams and tracking ... plan.Distribute key study documents to the CRO and vendors as appropriate.Provide clinical administrative support to the study teams. This may include… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Job Summary: Senior clinical operational leader accountable for operational planning and execution of FIH, ... clin pharm patient studies, and Phases 1-3 clinical trials at the study and program level. Responsible...start up, and monitor the overall agreed budget against trial progress. Work closely with internal and external stakeholders… more
- Merck & Co. (Rahway, NJ)
- …literacy principles preferred.Ability to prepare, with minimal oversight, a summary of a clinical trial design, objectives and activities for a lay audience per ... GCTO organization prepares a variety of regulated documentation in support of the clinical development portfolio and... Clinical Research, Clinical Study Design, Clinical Testing, Clinical Trial Compliance,… more
- Genmab (NJ)
- …accountable for driving the strategy, quality, and integrity of external data across the clinical trial portfolio. This role serves as a Subject Matter Expert ... to interpret discrepancies and resolve data issues.Cross-functional CollaborationCollaborate with Trial Management, Clinical Operations, Medical, Biomarker Management,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and laboratory data expertise to promote and implement best practices across the Clinical Trial lifecycle.- Applies GCP principles to ensure all laboratory data ... similar environment (eg, CRO); oncology, immunology, or complex disease Strong knowledge of Clinical trial data systems and/or EDC lab management. required- 4+… more
- Genmab (NJ)
- …Global Medical Writing team, you will drive the development of high-quality clinical documents to support operational, medical, and regulatory activities across ... us tell the story of our science through compelling clinical and regulatory documents. You'll be at the heart...also be involved in developing processes and tools to support further development of the department.The ideal candidate is… more
- Genmab (NJ)
- …of all aspects of clinical drug development, with particular emphasis on clinical trial design, trial execution, and strong knowledge about the ... feasibility and allocation process of a program and/or study.Must understand the Clinical Trial matrixed process from research through post-marketing Phase IV,… more
- Genmab (NJ)
- …(tables, listings, and figures)(Preferred) Practical knowledge and experience using R to support clinical trial analyses.About YouYou are genuinely ... support the Data Management, Statistics, Drug Safety, Medical, Clinical Pharmacology and Biomarker functions with the above by...in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and leads technical teams in preparation of submission documents to include clinical trial applications/amendments (eg, IND, IMPD, IB) and marketing ... this position has direct interaction with research laboratory members, the Contract Manufacturing Organization (CMO), Labeling members and Clinical members.… more
- Eisai, Inc (NJ)
- …includes overseeing the daily global eTMF system related activities relating to clinical study Trial Master Files (TMF), ensuring regulatory inspection-readiness ... and regulations. The Eisai eTMF system has global users, including contract research organizations (CROs) which requires individual and appropriate access rights… more
- Texas A&M University System (College Station, TX)
- Job Title Clinical Trial Support - Contract Administrator Agency Texas A&M University Department Research Compliance & Biosafety Programs Proposed ... and assists with the development of outreach programs related to human subjects research. Clinical Trial Support Services- Drafts, reviews, and negotiates… more
- Boehringer Ingelheim (Ridgefield, CT)
- …means working from the Ridgefield, Connecticut site 2-3 times per week typically. The Clinical Trial Contract Manager is responsible for the preparation, ... of agreements (eg, master services agreements, confidentiality agreements, Clinical trial agreements, etc.) + Reviews contract language and prepares… more
- HonorHealth (AZ)
- …of the study. The position's competencies include project management, clinical trial operations, coding/billing compliance, Medicare coverage analysis/budgeting, ... contracting, Clinical Trial Management Systems (CTMS), and basic finance and accounting...submission request through contract execution. Maintains the contract over the study life cycle to support… more
- University of Utah (Salt Lake City, UT)
- Details **Open Date** 05/19/2025 **Requisition Number** PRN41958B **Job Title** PS Manager, Clinical Research **Working Title** Clinical Trial & Post Award ... and alignment with key resources for the entire clinical trial portfolio. The incumbent will act...funders; review contracts/awards; support set-up and close-out; support compliance; prepare budget and contract amendments;… more
- ThermoFisher Scientific (Greenville, NC)
- …are completed and achieved according to the defined timelines without jeopardising the start of a trial . Support the Clinical CRO in the training of the CRAs ... and build relationship with our investigators. **Role:** Senior CTM, Clinical Trial Manager, FSP Dedicated **Location:** US,...Science Liaison) at LMA (Local Medical Affairs) who can support Clinical Operations at various steps (site… more
- Stanford University (Stanford, CA)
- … Clinical Trials Design certification. + Proven experience and extensive expertise in clinical trial activation. + Ability to understand clinical research ... Post Date May 27, 2025 Requisition # 106524 Stanford Cancer Institute - Clinical Trials Office Research Services ** Trial Activation Lead - Hybrid Position**… more
- Gilead Sciences, Inc. (Foster City, CA)
- …their aspirations. Join Gilead and help create possible, together. **Job Description** Clinical Operations is responsible for the worldwide execution of all Phase I ... - IV clinical trials across all Gilead therapeutic areas. ...including Phase I studies. + With guidance, may lead contract research organization (CRO) and vendor selection and, where… more
- Children's Hospital Boston (Boston, MA)
- …+ Supports strategies for marketing the hospital's research capabilities and clinical trial resources to industry. Identifies and evaluates potential ... 79870BRJob Posting Title:Senior Contract Specialist, Clinical Research OperationsDepartment:Research- ...assist faculty members and research groups in obtaining commercial support . + Advises on quality improvement efforts by providing… more
