Global Trial Leader - Sponsor Dedicated (Medical Affairs)

21.09. | Position with re­spon­si­bil­i­ties | 100%

Global Trial Leader - Sponsor Dedicated (Medical Affairs)

As a Global Trial Lead (Medical Affairs) you will have global accountability at the trial level and will be accountable for providing operational expertise for the successful cross-functional delivery of assigned global clinical trial(s), within agreed timelines and budget, and in alignment with all the applicable SOPs and regulatory requirements.  You will be accountable for the oversight of external service providers, planning and execution of both internally managed and outsourced trials, with scope from draft protocol elements document to availability of the Clinical Study Report and applicable disclosure of the trial results. Principal Responsibilities: 

  • Accountable for delivery of global trials within agreed/projected life of trial budget. Ensures accurate trial budget management, updates for scope changes and reconciliation of assigned trials for both out of pocket costs and FTE costs

  • Lead the cross-functional trial team; tracking of project deliverables & timelines using functional planning tools and support.

  • Proactively manages that trial deliverables and milestones are met. Identifies risks and ensures mitigation and contingencies are being initiated and followed through (including management of CAPAs).

  • Accountable for the oversight of all external service providers used for the trial for both inhouse and outsourced studies. 

  • Ensures Trial is operationalised in compliance with global health authority regulations and guidelines and internal operating procedures and processes

  • Ensures Trial Team members have received the appropriate trial-specific training needed for their function

You are: Innovative, forward-thinking and delivery-focused. Here at PRA we want our employees to succeed and we enable this success through consistent training, development and support. To be successful in this position you will have: 

  • A Batchelors Degree, or equivalent required, preferably in Life Sciences (e.g. Biology, Chemistry, Biochemistry, Nursing or Pharmacy).

  • Extensive clinical research operational knowledge, project planning/management, communication and presentation skills.

  • Must have the ability to manage all aspects of execution of a clinical trial.

  • Experience managing or leading global or regional teams in a virtual environment is required.

  • Strong expertise in vendor management required.

  • Effective study team leadership skills and proven ability to foster team productivity and cohesiveness with flexibility to manage global or regional study teams in a virtual environment.

  • Excellent decision making skills and strong financial management skills are essential for this position.                                            

Your health, your family, your career, your money — the things that matter to you, matter to us. The benefits of PRA just get better and better. PRA Health Sciences is an Equal Opportunity Employer. We welcome and encourage diversity in the workplace. PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.