Start-Up Project Manager - 6 Month Rolling Contract

The Global CRO are looking for a Clinical Project Manager/Study Manager with start-up experience to help with multiple country trials and multiple studies simultaneously.

The role would include:

- EC and RA submissions across multiple countries
- Provides customer-focused leadership in the execution of the start up of sites in one or multiple Phase II through Phase IV clinical trials across all functional Site Start-Up (SSU) areas.
- Accountable for the delivery of activation-ready study sites on time, on budget, and in compliance with all applicable regulations.
- Responsible for managing all site start-up activities from site selection/recommendation through site-activation ready, developing integrated site start-up timelines, and reporting weekly progress to the project team Project Manager (PM) including plans to address potential risks/gaps.
- Serves as a regional SSU liaison for the project team. May contribute to the business development process by reviewing proposals, attending and presenting at client meetings.
- Performs the role for maintenance studies and assists more senior SSU PMs with complex global studies and programs in ensuring efficient production of all SSU deliverables across multiple functions.

REQUIREMENTS

-A Life Science or Nursing Degree
-Experience in clinical research, including previous CRA and Project Management Experience, study start up experience is also ideal.
-Experience in CRO sector is desirable
-Strong communication and interpersonal skills, including good command of English language
-In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and ICH guidelines

KEYWORDS: CLINICAL PROJECT MANAGER, STUDY MANAGER, START-UP, START UP, CRO, RA, REGULATORY, SUBMISSIONS, EC, CLINICAL, TRIALS

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