Clinical Trials Manager

Clinical Trial Manager (Project Manager)

 

Position Overview

 

Overall responsibility for relationships with Sponsors and management of the project team to ensure execution of project(s) in accordance with contractual timeline and budget obligations. 

 

Position reports to Director, Project Management.

 Responsibilities

 

Manage execution of project(s), in accordance with contractual obligations, across all disciplines (e.g., Regulatory Affairs/Operations, Field Operations, Clinical Management, Data Management, etc.) and provide accurate weekly updates on progress within each discipline.

 

Primary Company interface with sponsors on day-to-day basis.

 

Review final draft documents including, but not limited to, protocols, amendments, final study reports, study monitoring plans, data management plans, TeleTrial specifications and other project-specific guidelines.

 

Develop and Manage project team as a cohesive unit of line representatives.

 

Plan and conduct regular (e.g., bi-monthly) well-organized, productive project team meetings with timely reporting of issues, action steps decided, and results achieved. 

 

Ensure all project functions are conducted in accordance with Company SOPs (or applicable Sponsor SOPs) and all applicable regulatory requirements.

 

Conduct QC review of all reports sent to Sponsor(s) from the various project team members.

 

Manage contract deliverables.  Collaborate with Business Development in preparing Change(s) of Scope when necessary.

 

Manage project finances including monthly reconciliation of Finance/Project reports, assessing spend vs. budget by discipline and milestone status.

 

Review and approve monthly invoices to Sponsor(s).

 

Manage vendors (labs, packaging, etc.) efficiently.

 

Primary interface with IS for development of TeleTrial specifications and completion of user validation.

 

Lead and manage all aspects of Investigator/Coordinator meetings.

 

Provide project-specific training to appropriate Company staff and/or Investigator site staff.

 

Develop and maintain Project Team Membership List(s) in accordance with SOP PM 01.

 

Develop and maintain Project Binder of project-specific guidelines.

 

Provide input to the annual performance appraisal for each member of the project team.

 Assist Business Development in the development of proposals and participate in Business Development presentations for new business, as applicable.

 

 Requirements

 

BS, BA, RN or equivalent degree in a biological or related science field or proven excellence in Associate Project Manager role at Company.

 

Five years experience in clinical research, including at least two in pharmaceutical research.

 

Extensive knowledge of all applicable FDA regulations, GCP and ICH guidelines.

 

Extensive knowledge of the drug development process and clinical study management including study design, site recruitment and management, data management and reporting.  Good knowledge of at least one therapeutic field (e.g., CV, Oncology, CNS, etc.).

 

Ability to lead through a facilitative approach but with clear direction.

 

Clear resourceful thinking and good organizational abilities.  Effective communication and issue resolution skills.

 

 

Candidates should submit updated CV and cover to:

 

Audra Matlack

Director of Research

Genesis Consulting Partners 

Chesterbrook, PA 19087

 

484-228-8088 (Office)

amatlack@gcpbiosearch.com