Senior Clinical Trial Manager

Position Summary:

We are seeking a highly skilled and motivated Senior Clinical Trial Manager to join a fast-paced and collaborative team. The Senior Clinical Trial Manager will be responsible for the day-to-day operational oversight of assigned trial(s) in accordance with the protocol, standard operating procedures (SOPs) and GCP/ICH guidelines to support successful execution of the trial within timelines, budget, and with the highest quality.

Responsibilities:

• Manage all clinical operational aspects of a global clinical trial including start-up, conduct, and close-out activities.
• Monitor assigned trial for adherence to the GCP, protocol, SOPs, and other key performance indicators (e.g., review of monitoring reports, study tracking tools, etc.) to ensure proper oversight of the CRO and sites.
• Proactively identify potential study issues/risks and recommend/implement solutions.
• Manage CRO interactions, including sponsor oversight of operational functional activities (e.g., study management, monitoring, site management, project files) and serve as the primary CRO/vendor contact.
• Support the CRO to ensure quality and accurate data is generated and assist in resolving any issues (e.g., subject eligibility, deviations, etc.).
• Manage study timelines to align with corporate and cross-functional goals.
• Contribute to the writing, review, and finalization of protocols or components of clinical study reports.
• Prepare metrics and updates for Vera management.
• Organize and lead clinical operational meetings.
• Organize and lead study team meetings.
• Develop and maintain strong working relationships with principal investigators, key clinical opinion leaders, and sites.
• May contribute to development of RFPs and participate in selection of CROs/vendors as well as review of any CRO budgets and/or change orders.
• Develop strong cross-functional relationships and exhibit leadership skills with counterparts to ensure efficient execution of clinical trial.
• Ensure site and CRO adherence with SOP, applicable regulations, GCP, and ICH guidelines.
• Contribute to the development and/or review of study plans, ICFs, site manuals, patient materials, CRF completion guidelines, system specifications, etc.
• Attend and/or present at Investigator Meetings as needed.
• May travel up to 30%, as needed, to support clinical development programs.

Qualifications:

• A BS or higher in life sciences or health-related field.
• 5+ years of clinical development experience and progressive experience in clinical research within the pharmaceutical or biotechnology industry.
• Rare disease and inflammatory diseases and/or difficult enrolling study experience preferred.
• Regulatory filing and experience with inspection readiness preferred.
• Experienced in managing, mentoring, and developing junior staff.
• Flexible self-starter to operate in a fast-paced startup environment. Ability to develop out-of-the-box solutions with limited infrastructure.
• Experience in all aspects of clinical operations.
• Working proficiency of GCP, ICH guidelines, and FDA regulations.
• Ability to work independently as well as collaboratively in a cross-functional team environment.
• Proficiency with MS Office (e.g., Word, Excel, PowerPoint, Outlook, Project).
• Strong interpersonal skills with excellent oral and written communications.
• Innovative, analytical, and extremely organized to drive projects to completion.