Job DescriptionTitle
Sr/Clinical Trial ManagerReports to VP Clinical Operations or other designee within Clinical Operations
Direct Reports None
PurposeThe Sr/Clinical Trial Manager is responsible for execution and coordination of all activities required to initiate, manage and complete clinical trials working closely with the VP, Clinical Operations or designee. CTM will serve as the primary point of contact for CROs and incorporate study logistics and planning to accomplish study objectives in a highly dynamic and complex environment in accordance with appropriate quality standards including GCP/ICH requirements and company's SOPs.
This position will manage essential duties and responsibilities as independently as possible, with guidance and oversight provided by the VP, Clinical Operations or designee when needed. This job contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs. The Sr/Clinical Trial Manager will report into the VP, Clinical Operations or designee
Responsibilities - Oversee and manage all or some aspects of a clinical trial in accordance with Company SOPs, ICH/GCP regulations and study-specific manuals and procedures.
- Maintain study timeline
- Identify and ensure compliance with key study quality metrics and determine appropriate action in conjunction with Study Team
- Align study start-up, enrollment, study conduct and close-out activities with project goals
- In collaboration with the study team, identify risks to study and develop risk mitigation plans, including communication with management when necessary.
- Review monitoring reports and monitoring visit letters to assess trends and site performance
- Write or contribute to preparation of clinical protocols, amendments, informed consent forms, study manuals, and study plans, electronic case report forms, and any other clinical research related documents in collaboration with the study team
- Create and implement study-specific tools to ensure clean data and timely data entry working with biometrics group, and perform clinical data review of data listings and summary tables, including query generation as needed
- Organize and manage internal team meetings, investigator meetings and other trial-specific meetings.
- Assist in identification, evaluation and hiring of appropriate CROs and other third party study vendors in accordance with Company SOPs.
- Oversee performance of CRO, third party vendor(s) associated with the clinical trial, and field CRAs including co-monitoring, to ensure compliance with study protocol and in accordance with scope of work; identify areas of concern and escalate to VP, Clinical Operations or designee
- Develop and maintain good working relationships with investigators and study staff
- Perform initial review of CRO and other third party study vendor invoices
- Assist with CRA and third party vendor training on protocols and practices
- Identify, select, and monitor performance of investigational sites for clinical studies
- Review or approve of IMP release packages. Manage investigational product (IMP) accountability and reconciliation process
- May negotiate and manage the budget and the payments, in collaboration with the VP, Clinical Operations or designee
- May manage and/or mentor other team members
- Track and report on progress of study including site activation, patient enrollment, monitoring visits
- Identify and share best practices and process improvements with colleagues to ensure optimal efficiency and consistency in Clinical Operations. Lead or participate in functional initiatives and/or activities as assigned.
Qualifications - To be successful in this role, top candidates have the ability to work well within a team and with other accomplished professionals within and across functions/teams, able to work in a fast paced-environment, have the sense of urgency and therefore able to multi-task and shift priorities rapidly to meet tight deadlines. Must have demonstrated problem solving abilities and strong organizational skills. Enthusiastic, self-motivated and keen to improve processes and overcome inefficiencies.
Requirements - A Bachelor's degree or equivalent in life-science is required.
- At least 6 years biotech or pharmaceutical development experience with at least 2-3 years trial management experience is required.
- Hematology experience is highly preferred.
- Experience in Phase I-II clinical trials oncology is required.
- Experience in CRO selection and management is preferred.
- Knowledge of FDA and GCP/ICH requirements and medical practice/techniques and terminology.
- Excellent written and verbal communication skills are required.
- Proficient with Microsoft Office (Word, Excel and Power Point) and other electronic systems (CTMS, EDC and eTMF).
- Fluent English is required.
- Available to travel as needed.
- Four days per week in the office
