Clinical Trials Project Manager

Roles/Responsibilities

Contribute to the overall strategic planning of clinical development programs

Interact with and integrate study plans from other departments into an overall clinical trial strategy

Establish and update clinical project plan

Develop and manage clinical project budget

Prepare clinical protocols and amendments

Develop or approve monitoring plans

Approve the design, format and content of (e)CRFs, study guides and subject instructions

Oversee activities associated with clinical site start-up

Ensure appropriateness of forecast for investigational product and clinical supplies

Manage Investigator Meetings

Manage the overall Investigational product accountability and reconciliation process

Provide study-specific outsourcing specifications for RFPs

Assist in preparation Clinical Study Reports, Annual IND safety reports and ASRs


Skills/Experience

University degree in medical sciences or equivalent through experience

Minimum 6 years related experience in life sciences or medically related field, including 4 to

6 years clinical project management experience.

Excellent knowledge of English

Proficiency in the preparation and review of clinical sections of study reports

Experience with management of multinational clinical trials

Knowledge of cardiovascular (thrombosis) therapeutic or product area (desired, not mandatory)

Experience in preparation of clinical sections of CTA/MAA/IND/BLA (desired, not mandatory)


Personal Attributes

Ability to use scientific and clinical knowledge to conceptualize study designs

Effective written and oral skills especially with regard to scientific and clinical issues

Ability to anticipate and resolve problems

Ability to work effectively in a team/matrix environment

Excellent interpersonal, organizational, supervisory and project planning skills.