Industry: Pharmaceuticals & Biotech•
5 - 7 years
Posted 171 days ago
The Clinical Trial Manager is responsible for the overall management, execution and oversight of phase I-IV clinical trials from start up through CSR, including but not limited to: development of project documentation, training project staff, monitoring study progress, assessing protocol adherence, administration and oversight of study budgets, management of third-party vendors for clinical services, management of project timelines and deliverables. Works within a multidisciplinary team composed of clinical research, pharmacovigilance, regulatory, business development, and commercial staff as well as investigative site staff and consultants and CROs to achieve departmental goals.
Develops and coordinatesclinical trial and operational activities and manages their execution to ensure completion according to project timelines andbudget.
Coordinates and leads cross-functional project team meetings that include representatives from multiple internal departments (eg, Medical Science, Regulatory Affairs, Data Management), prepares agendas and distributes meeting minutes.
Reviews and contributes to protocols, amendments, case report forms (CRFs), and clinical study reports (CSRs). Develops informed consent documents.
Coordinates the qualification and selection of investigative sites, plans for and presents at Investigator Meetings, develops other site training materials.
Develops clinical trial timelines, enrollment projections, documents and instructional materials in support of trial execution, including project, communication, monitoring, recruitment, and risk mitigation plans.
Partners with vendor management in identifying appropriate vendors for possible selection. Participates in the vendor selection process, including input and review of the draft RFP, review of returned RFPs, bid defense meetings, audits, and final vendor selection.
Manages vendor and CRO activities, and tracks internal and external (CRO/vendor) project deliverables to ensure they remain within the timeline and budget.
Establishes and maintains regular contact with investigators, vendors and study site staff to ensure GCP/ICH/protocol compliance, and compliance with Pacira SOPs.
Performs sponsor oversight of monitoring visits, including site qualification, study site initiation, routine monitoring and study site closure visits including review of monitoring reports and follow-up letters.
Responsible for ensuring the development and updating of cost estimates at the study and project level.
Partners with Finance team in developing complete clinical trial external cost estimates (sites and vendors) and maintains responsibility for the management of the clinical trialbudget.
The qualified candidate will possess the following:
Bachelor’s degree in Life Sciences from an accredited College or University
Demonstrated knowledge of FDA regulations and Good Clinical Practice (GCP) Guidelines as they relate to protection of human subjects.
Demonstrated knowledge of Electronic Data Capture, IRT, CTMS and eTMF systems.
Experience in mentoring and/or supervising junior staff.
Proficient in MSOffice including, Outlook, Word, Excel, PowerPoint and MSProject.
Minimum 2 years of independently managing clinical studies.
Minimum of Six (6) years clinical research experience in the U.S. biotech/pharmaceutical industry.
Ability to travel up to 25% of the time including some weekends.
Demonstrated working knowledge of cGCP, ICH and other relevant clinical development and FDA regulations and processes.
Excellent written and oral English communication and presentation skills.
Ability to successfully interact and communicate with variety of professionals at all levels of the organizations with whom s/he interacts
Demonstrated knowledge of and commitment to abiding by ethical standards in research.
Excellent analytical, organizational and time management skills.
Ability to work effectively on a team in an entrepreneurial environment.