Clinical Trial Leader Job

CLINICAL TRIAL LEADER needed for a CONTRACT opportunity with Yoh's client located in Cambridge, MA.

WHAT YOU'LL BE DOING:

- 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.
- 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.
- 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.
- 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.

WHAT YOU NEED TO BRING TO THE TABLE:

- BA/BS in Life Science/Healthcare
- Four (4) or more years technical, operational and managerial experience in planning, executing, reporting and publishing clinical studies in a pharmaceutical company or contract research organization.
- 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.

OPPORTUNITY IS CALLING, APPLY NOW!

RECRUITER: Krista Leach

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

J2W: CLINICAL

MONJOB

J2WNECLIN

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SFSF: REN