Sr. Clinical Trials Associate

The Senior Clinical Trials Associate (CTA) is an integral member of the Clinical Development Operations team, leading the planning, implementation and management of early and late phase clinical research studies.  The CTA of Clinical Operations is responsible for creating and managing study timelines, budgets and study management plans in a fully outsourced model.   This role provides oversight of Clinical Research Organizations (CROs) and other vendors and may author, review and approve various study related documents and plans.  The CTA reports to Clinical Operations for the assigned program, and offers the chance to join a team of passionate colleagues with the opportunity for career growth.

Manage the cross-functional study team to execute and deliver clinical studies in accordance with clinical development plans/strategy and timelines.

Oversight of CROs and other external vendors to ensure successful clinical trial implementation and execution.

Anticipate, recognize and resolve issues; as necessary, manage escalation of study related issues as needed.

Review and approve study-related plans generated by CROs and vendors, and ensure the documentation is in accordance with GCP regulatory requirements and consistent with the protocol for assigned studies.

Ensure audit-ready condition of clinical trial documentation including the trial master file.

Review monitoring reports to ensure quality and resolution of site-related issues.

Liaise with clinical site staff and Investigators as appropriate to ensure optimal Sponsor-site relationships.

Lead planning and conduct of investigators’ meetings.

Monitor progress of clinical study activities and report on the progress of assigned clinical trials including budget and timelines.

May perform periodic visits to sites and/or CROs to assess progress of studies/protocol compliance.

Participate in the preparation and review of SOPs.

• Bachelor’s degree or equivalent degree or equivalent by experience.
• Typically, 6+ years of experience in life sciences or medically related field, including at least 3+ years of relevant clinical development experience (e.g., in clinical research, study management, etc.) in Biopharmaceutical Industry.
• Experience in oversight of CRO study execution required.
• Experience in oncology and/or cellular therapy is preferred.
• Thorough knowledge of FDA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies globally.
• Extensive experience managing complex protocols, CROs, budgets, and timelines
• Experience monitoring clinical studies and conducting SQVs, SIVs, IMVs, and COVs preferred
• Strong interpersonal skills to interact with investigators, vendors, and individuals at all levels of the organization.