SR. CLINICAL TRIAL MANAGER

Responsibilities

• Develops, leads and coordinates clinical trial activities and manages the execution of 1 or more clinical trials/programs, ensuring completion according to timelines and study budget.
• Coverage of IND submission documents, protocols/amendments, ICFs and site budget and CTAs.
• Supports the development of operational strategies including country and site feasibility and selection, CRO and vendor identification and selection.
• Contributes to the development and management of the trial timelines, budget, and study plans, including vendor oversight, risk management, safety, and communication.
• Supports development and maintenance of vendor contracts and budgets in collaboration with the Sr. Director of Clinical Operations, legal and finance.
• Manages and tracks study specific payments and flags any variances.
• Reviews site visit reports, under the direction of the Clinical Operations Leadership.
• Maintains accurate tracking and reporting of study metrics to support the conduct of the clinical trial(s) from start-up to close-out.
• Coordinates investigational product release activities across clinical sites.
• Ensures sites have all the appropriate non-clinical supplies (e.g. lab kits) through close collaboration with the relevant vendors and management of the supplies.
• Provides operational input in the development and review study documents (e.g., protocol, informed consent form, eCRF, site instructions, diaries, lab manual, Pharmacy Binder, Study Management Plan, etc.) and clinical site documents (e.g., site specific informed consent forms).
• Pairs with Data Management and Clinical Science to oversee eCRF development, data completion and data quality issues.
• Builds and maintains effective working relationships with all relevant stakeholders across and up and down the organization and with CROs, external vendors and partners.
• Coordinates communication of tracking information within the study team and to the clinical sites.
• Attends departmental and study specific meetings.
• Leads the study execution team in collaboration with the medical lead.
• Takes minutes during meetings.
• Aids in editing slide presentations, graphs, etc.
• Contributes to the development and review of Standard Operating Procedures.
• Aids in the preparation of Investigator and Study Coordinator Meetings.

Qualifications

• University/college degree in health care (or other scientifically related discipline) or equivalent education and clinical licensure (eg. LVN, RN, etc.) with significant clinical trial management experience is required.
• Bachelor’s degree is preferred.
• 7+ years of experience with 5+ or more years of experience in clinical operations, study coordinator, data management, site monitoring and/or nursing experience preferred, however, other relevant experiences and skills may be considered by the hiring manager when considering the candidate’s eligibility.
• Understanding of ICH/GCP and knowledge of regulatory requirements (eg. ICH/CFR guidelines).
• Experience of working as part of a large team, clear written and verbal communication skills and ability to partner with various stakeholders are critical for success in this role.
• Proven ability to proactively identify and resolve/refer project-related operational issues; ability to work independently on routine assignments, or under supervision on new assignments.
• Ability to handle a moderate volume of highly complex tasks within a given timeline. Requires strong organizational skills, attention to detail and ability to prioritize and problem solve.
• Willingness to travel as necessary, consistent with project needs.
• Computer proficiency (Outlook, MS Word, Excel, and PowerPoint).
• Some travel (domestic and international), up to 15%.