Clinical Trial Manager/ Sr. Clinical Trial Manager

at  TSP A Syneos Health Company

PREFERRED EDUCATION

• BS degree or equivalent required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, and Pharmacy).

PREFERRED EXPERIENCE

• Minimum of 6 (7 years for Sr CTM) years of clinical trial experience in the pharmaceutical, biotech industry, clinical trial site, or CRO, with at least 1-2 of those years managing clinical trial activities.
• Sr. CTM requires experience managing a CRO, as well as a complex study in a previous Clinical Trial Manager or Clinical Project/Program Manager position.
• Experience in the set-up and management of third-party vendors, as well as study start-ups.
• Experience with phases 1 & II clinical trials. Phase III & global trial experience are a plus.

KNOWLEDGE, SKILLS, AND ABILITIES

• Thorough knowledge of FDA, CFR, and ICH GCP requirements and other regulatory requirements.
• Strong leadership and management skills to provide planning, coordination, and direction to staff and ability to propose innovative solutions to challenges.
• Outcome driven; can thrive in a fast-paced environment with rapid change while effectively managing pressure in a professional manner.
• Able to set up and track key metrics and motivate a study team throughout the project life cycle.
• Proven interpersonal skills with the ability to build strong relationships cross-functionally and with clinical sites, vendors, consultants, and CROs.
• Proficiency with MS Office products Word, Excel, PowerPoint, Outlook) and other electronic systems (CTMS, EDC, and eTMF). Experience with Smartsheet is desirable.
• Flexibility in work hours as needed to accommodate international collaborators or significant meetings/events. Flexibility for some remote and in-person combination on a weekly basis.
• Up to 25% travel (US and international) may be required.

EQUAL OPPORTUNITY EMPLOYER/PROTECTED VETERANS/INDIVIDUALS WITH DISABILITIES

Curevo is proud to be an equal opportunity employer and does not discriminate on the basis of race, color, citizenship status, national origin, ancestry, sex, sexual orientation, age, religion, creed, physical or mental disability, medical condition, marital status, veteran status, or any other characteristics protected under applicable federal, state, and local laws.

PURPOSE

TheClinical Trial Manageris responsible for the execution of our ongoing clinical trials in accordance with the appropriate quality standards including ICH-GCP Guidelines, SOPs, and applicable regulations.

KEY ROLES AND RESPONSIBILITIES

• Overall study execution on one or more clinical trials. Oversee set-up, ongoing quality review, and final reconciliation of study documents including review of site regulatory documents/packages for Sponsor oversight of CRO and site activities
• Ensure study regulatory files are collected, inventoried, and filed as per ICH GCP and sponsor requirements.
• Assist in the preparation and follow-up of in-house and on-site quality audits, as well as regulatory authority inspections.
• Develop requirements/specifications for outsourcing to vendors. Works with the Program Management team for review of vendor proposals, contracts, and budgets for accuracy with respect to the clinical trial protocol and trial activities. Review vendor invoices for accuracy as needed.
• Oversee clinical monitoring (site qualification, site initiation, interim monitoring, clinical trial closeout visits) and other vendor activities to confirm integrity, accuracy, and accountability of trial activities, clinical and research lab data ensuring compliance with the protocol, study manuals, IRB, ICH Good Clinical Practices (GCP), CFR, FDA, and applicable regulations. Perform sponsor audits of investigative sites and vendors.
• Coordinate with CRO and data management for database cleaning, soft lock, and final database lock and ensuring data timelines are met. Assist with guidance and review of tables, listings, and figures for interim analysis or final data output. Coordinate with biostatistics in the transfer of final data for statistical analysis and coordinate the review of statistical analysis plans by subject matter experts as assigned.
• Coordinate with the CMC team for investigational product (IP) supply and any IP issues identified on-site during the clinical trial.
• Partner with consultants as assigned for review and obtain advice on clinical, and laboratory questions. Compile clinical trial operations materials and updates for consultants, the Scientific Advisory Board, and the Curevo Board of Directors.
• Contributes to the development of abstracts, presentations, manuscripts, and other external forms of communication.
• Other activities may be assigned as required.