The Clinical Trials Manager (CTM) is responsible for execution and coordination of all activities required to initiate, manage and complete clinical trials working closely with Clinical Program manager. CTM will serve as the primary point of contact for CROs and incorporate study logistics and planning to accomplish study objectives.
Responsibilities include but are not limited to:
- Acts as a clinical trial lead on a large clinical trial or as a regional lead on a global study.
- Maintains study timelines.
- Identifies and ensures compliance with Key Performance Indicator (KPI); Key Risk indicators (KRI); and Key quality indicators (KQI) for assigned clinical trials.
- Aligns study start-up, enrollment, study conduct and close-out activities with project goals.
- Works closely with project teams to develop clinical trial protocol and designs all associated clinical forms, including Case Report Forms, SAE Forms, etc. for assigned clinical trial.
- Proactively identifies study issues/risks and recommends/implements solutions for assigned clinical trial.
- Reviews monitoring reports and monitoring visit letters to assess trends and site performance.
- Prepares, reviews and approves study-related documents (e.g., Monitoring plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, CRF Completions Guidelines and Clinical Study Report).
- Create and implement study-specific tools to ensure clean data and timely data entry working with biometrics group.
- Organizes and manages internal team meetings, investigator meetings and other trial-specific meetings.
- Ensures studies are carried out according to the study protocol, SOPs, CFR, ICH/GCP guidelines and study-specific manuals and procedures; collaborates with clinical program manager to ensure inspection readiness.
- Assists in the preparation and follow-up of in-house and on-site quality audits, as well as, regulatory authority inspections.
Vendor and Site Management
- Participates in and facilitates the CRO/vendor selection process working closely with CPM/AD for assigned clinical trial.
- Manages vendors associated with the trial per transfer of obligations and provides metrics and updates for management.
- Manages site related interactions and serves as a liaison and resource for investigational sites.
- Provides CRO oversight for assigned clinical trial activities including sponsor oversight of operational functional activities working closely with CPM.
- Review vendor invoices for accuracy.
- May assist to develop and revise scope of service agreements, budgets, plans, and detailed timelines ensuring that performance expectations are met with the CRO.
- Participates in the selection, training and evaluation of study personnel (contract and internal) to insure the efficient operation of the function.
- May manage and/or mentor other team members.
- Develops and implements study specific processes.
- Fosters effective and collaborative working relationships with fellow employees, management and external partners.
Qualifications and Education
- University degree and a minimum of 6 years of clinical trials experience in pharmaceutical, biotech or CRO setting and clinical trial management experience. Related experience in drug development, and on-site monitoring or an equivalent combination of education and experience.
- Experience in Phase I-III clinical trials.
- CRO management is preferred.
- Oncology clinical research experience preferred.
- Proven interpersonal skills with the ability to work collaboratively as a member of a cross-functional team.
- Excellent communication and organizational skills and the ability to work effectively in a high paced, fast changing environment.
- Thorough knowledge of CFR and GCP/ICH requirements.
- Exceptional attention to detail.
- Proficiency with MS Office products Word, Excel, PowerPoint, Share point) and other electronic systems (CTMS, EDC and eTMF).
- Previous experience with database build an asset.
- Ability to travel for site co-monitoring activities, vendor visits/audits as required (up to 30%).
- Remote candidate may be considered.
- Smartsheet experience may be helpful.