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Clinical Project Lead III

New Haven, CT 06501

Posted: 02/23/2023 Employment Type: Contract Industry: Medical Affairs Job Number: 11089 Pay Rate: $80.00 - $84.00

Job Description

Our client is a global biopharmaceutical company focused on developing and delivering life-transforming therapies for patients with devastating and rare disorders.


Duties:
  • You will be responsible for: Accountable for the planning, implementation and execution of pivotal clinical trials, non-interventional and post-approval commitment studies (eg, Post-Approval Safety Surveilance (PASS) studies), and/or early access programs, including study deliverables, milestones and data quality.
  • Lead the Clinical Trial or other study Team.
  • Provide management oversight of CROs and relevant study vendors.
  • Oversee third party vendors to operationalize the study specifications.
  • Directs operational execution of study activities in accordance with Company SOPs, ICH Guidelines, and Good Clinical Practices (GCP), Good Pharmacovigilance Practices (GVP) to ensure overall data quality, integrity; and patient protection as applicable.
  • Accountable for planning, tracking and forecasting the Global Clinical Operations budget and timelines for the studies against the agreed goals.
  • Develops and maintains budgets for study(s) that include short and long-range clinical forecasting and monthly accruals based on clinical activity to support Clinical Development or Global Medical Affairs financial goals.
  • Manages CRO relationship to ensure the appropriate scope of work, oversight and training of clinical investigators and achievement of study milestones within agreed upon timelines and budget.
  • Communicates clinical studies performance data to other members of the management and scientific team.
  • Prepare and maintain required study and regulatory documentation, e.g.:, reports for Competent Authority submissions, master patient informed consent, Monitoring Plan, Pharmacy Manual, Investigator Agreements and budgets.
  • Key contributor to the development, review and approval of study documents including but not limited to protocol, ICF, statistical analysis plan, and clinical study report.
  • Conducts lessons learned exercises to provide continuous process improvement and sharing of best practices.
  • Participate in and/or lead deparmental initiatives.

Job Requirements

You will need to have:
  • >10 years of clinical research experience, 5 of which in a leading role accountable for the planning and execution of global clinical trials, non-interventional, relevant post-marketing studies, and/or early access programs.
  • Bachelors degree or equivalent in one of the disciplines related to clinical practice/health care, life sciences, or drug development.
  • Ability to lead cross-functional teams and to provide management oversight of CROs.
  • Experience in developing study budgets, forecasting and financial oversight of a project.
  • The duties of this role are generally conducted in an office environment.
  • As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.

We would prefer for you to have:
  • Advanced degree (Master, PhD, MD) is desirable.
  • PMP certification desirable.

Meet Your Recruiter

Lisa Weiss
Senior Recruiter, Account Manager

As a Recruiter at Compass, Lisa has a long history of working with candidates in many different industries. Lisa was drawn to the life science industry because she feels her best work is done when she’s connecting candidates to jobs that make a big impact on the world.

Lisa is passionate about her candidates and feels most rewarded when she helps them land their dream job. She will walk you through the opportunities and guide you so that you can share your best self to the employer.

When Lisa isn’t working, she enjoys fitness, travel, and spending time with her husband and two children.  And yes, if her voice sounds familiar to you it’s because she’s a famous voice over star.

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