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 identifies potential study issues/risks and recommends/implements solutions.
• Manages CRO interactions, including sponsor oversight of operational functional activities (e.g., study management, monitoring, site management, project files) and serves as the primary CRO/vendor contact.
• Supports the CRO to ensure quality and accurate data is generated and assists in resolving any issues (e.g., subject eligibility, deviations, etc.) .
• Manages 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.
• Prepares metrics and updates for Vera management.
• Organizes and leads clinical operational meetings.
• Organizes and leads 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 participates in selection of CROs/vendors as well as review of any CRO budgets and /or change orders.
• Develop strong cross-functional relationships and exhibits leadership skills with counterparts to ensure efficient execution of clinical trial.
• Ensure site and CRO adherence with SOP, applicable regulations, GCP, and ICH guidelines.
• Contributes 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:

• BS or higher in life sciences or health-related field.
• 5+ years 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 start-up environment. Ability to develop out of the box solutions with limited infrastructure.
• Experience is all aspects of clinical operations.
• Working proficiency of GCP, ICH guidelines and FDA regulations.
• Ability to work independently as well as collaboratively in 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.