Previous Job
Previous
Clinical Study Lead
Ref No.: 18-01347
Location: Waltham, Massachusetts
Position Type:Contract
Shift:First
Job Category:Research & Dev
Benefits:Medical Insurance
The Clinical Study Lead is responsible for the overall delivery of assigned clinical study/studies by under a program and demonstrates a high level of knowledge of clinical operations.

The Clinical Study Lead is responsible for the overall delivery of assigned clinical study/studies by under a program and demonstrates a high level of knowledge of clinical operations’ methodologies, organizational, project management and leadership capabilities as well as decisiveness and strong judgment.

This is a 1 year contract role.

Responsibilities Include:
  • Delivery of assigned clinical study/studies, with cross functional stakeholder alignment and ability to drive team and CRO against contracted budget and timelines.
  • Proactively and independently manages vendors, including identifying risks and outlining mitigation plans, as well as escalation of issues in a timely manner.
  • Ensures comprehensive approach to site and monitor oversight is in place, which includes development of quality and performance metrics; study specific approach to site management and remote monitoring in place.
  • Provides operational oversight including but not limited to activities such as study plan generation and approval, monitoring activities, supply logistics, site visits.
  • Provides leadership to multifunctional Study Management Teams and acts a main point of contact for CRO on study progress, issues and mitigation plans.
  • Provides oversight to study support staff (ie CTA, CTC, CTM).
  • Actively participates in initiatives and process improvements contributing to functional excellence in Clinical Operations
Qualifications:
  • 8+ years’ experience in pharmaceutical industry and/or clinical research organization, including 5+ years clinical study management.
  • Demonstrated leadership of global clinical studies in collaboration with CROs, including identification of issues and risks, establishing mitigation plans, oversight of CRO and maintaining quality of study data.
  • Excellent teamwork, organizational, interpersonal, and problem solving skills.
  • Experience in gene therapy, rare disease and/or hematology is a plus.
  • Demonstrated excellence in project/program management and matrix leadership.
  • Expertise in global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, and ICH GCP. Awareness of local country requirements.