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Clinical Study Lead
Ref No.: 18-03073
Location: Waltham, MA, Massachusetts
Start Date / End Date: 03/19/2018 to 03/15/2019
Job Title: Clinical Study Lead
Duration: 1 year
Location: Waltham, MA

Job Description:

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.

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
Experience: 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
BS Degree

Shiva Prasad | Senior Recruiter
Sunrise Systems Inc.
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