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Clinical Trial Leader

Job Description

 


  1. Lead the clinical protocol development process in collaboration with the Clinical Program Leader (team MD): responsible author for clinical protocols, amendments and related documents; contribute to the medical/scientific input given for the development of trial-related documents and processes which reside in other line functions; obtain approval from internal review boards.
  2. Contribute to the development of clinical sections of regulatory documents like Investigators’ Brochures, briefing books, safety updates, IND/NDA submission documents, responses to Health Authorities questions.
  3. Investigator/site relationship management is vital; must develop effective working relationship with key investigators in assigned therapy area to optimize scientific quality/innovation of clinical study design, execution, reporting and publication.
  4. Lead and matrix manage the global multidisciplinary Clinical Trial Team (CTT) to ensure all trial deliverables are met according to timelines, budget, and resource requirements; Engages the input of line functions at the appropriate time. Leads trial level interactions with Global Monitoring Operations and other relevant functions including Integrated Medical Safety and Drug Supply Management.
  5. In collaboration with the CPL lead the clinical trial data ongoing medical/scientific review, final analysis and interpretation including the development of clinical trial reports, publications and internal/external presentations.
  6. Prepare and run dose escalation meetings with investigators. Coordinate the real time availability of quality clinical trial data, including safety, efficacy, pharmacokinetic and biomarker data, to provide consolidated information for dose escalation meetings with investigators.  
  7. Develop clinical outsourcing specifications to facilitate bid templates and selection of CROs and other 3rd parties; manage interface with external vendors in cooperation with the CRO Management Department.
  8. For OTM trials led by a US-based clinical trial leader, function as local trial leader (LTL) for all US activities including working closely with US GMO for all study start-up activities including regulatory documents, budget, contract agreements and all activities pertaining to updates as dictated by amendments.  As the LTL be the primary contact for US sites for clinical conduct of the trial.


Job Requirements

  • BA/BS degree
  • 4+ years technical, operational and managerial experience in planning, executing, reporting and publishing clinical studies in a pharmaceutical company or contract research organisation.
  • Good knowledge of Good Clinical Practice, clinical trial design, statistics, regulatory processes, and global clinical development process.
  • Knowledge of oncology and/or hematology, or experience in early clinical development preferred.
  • Hands-on experience in data cleaning and analysis recommended.
  • Good communication, organization and tracking skills.



NO sponsorship, NO relocation.  US based candidates only, please

Qualified candidates, please send current Word resume to: [Click Here to Email Your Resumé] for immediate consideration


Job Snapshot

Contact Name Marci Peister
Post Date 7/22/2014
Location Boston, MA
Employment Type Contractor
Job Type Science, Biotech, Pharmaceutical
Education 4 Year Degree
Experience At least 4 year(s)
Manages Others No
Industry Biotechnology, Pharmaceutical
Required Travel Not Specified
Job ID 3952819
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