Senior Clinical Trial Manager

Employer
HiberCell
Location
New York, NY, United States
Posted
Sep 23, 2020
Ref
31144042
Hotbed
NextGen Bio
Required Education
Doctorate/PHD/MD
Position Type
Full time
The Senior Clinical Trial Manager position is responsible for providing professional project management of assigned complex U.S. and global pharmaceutical development projects. The incumbent has responsibility for managing cross-functional teams toward implementation of the operational plan for assigned indication/study. The individual works with Pharma leaders to ensure the organizational and project objectives are achieved.

Responsibilities

The successful candidate will:
  • Work with the Pharma team to draft and implement overall development strategy of assigned indication, inclusive of Clinical Development Plan, protocols, budgets, and timelines
  • Manage internal and external team members, communications, and project meetings and cross-functional timelines and achievements (CMC and pre-clinical)
  • Manage, track and coordinate clinical operational activities specified in Clinical Development Plans (CDP) for their assigned indication(s) and/or study(ies) including, but not limited to:
      • Writing/coordinating the publication of the protocol, clinical management plan, monitoring plan, study-related manuals, and SOPs, as necessary
      • Directing all third -arty vendor clinical activities including CROs, investigative sites, central and imaging laboratories in addition to managing importation/exportation of clinical trial materials
      • Overseeing development and implementation of the clinical and safety databases, statistical analysis plans, CRFs, and data validation plans; managing the writing and finalization of the final clinical study report
      • Managing applicable timelines and budgets
      • Managing internal and external team members, communications, and project meetings
      • Tracking external vendors and consultants including contracts, scopes of work, deliverables and variances from the budget
      • Maintaining regulatory files and correspondence, including authoring portions or all of Annual Reports, Investigator Brochures, and scientific abstracts
  • Assess out-sourcing requirements with VP, Clinical Operations and other regulatory, pharmacovigilance, and CMC team members, setting criteria for and reviewing requests for proposal (RFP) from CROs in collaboration with appropriate legal, financial, operational and clinical research functions.
  • Develop and foster outside relationships with key opinion leaders, collaborating researchers, and research sites.
  • As required, serve as monitor and/or auditor on selected projects.

Candidate Qualifications:

Preference will be given to candidates with the following qualifications:
  • PhD in biological sciences with a minimum of 5 years of relevant experience or MS/BS/BA with minimum of 10 years of relevant experience.
  • Experience with oncology indications and international/multi-country studies Phase 1-3 studies.
  • Knowledge of clinical study designs and FDA, ICH, and regional regulations as well as cross functional clinical operations/processes.
  • Strong verbal written and oral communication, problem solving, and interpersonal skills.

Travel Requirements:
  • Minimal travel; some US and international travel may be required