Job Title: Senior Clinical Trial Manager
Manages overall operation of the entire clinical study (or studies) including project planning, budget, resource management and Contract Research Organization management. Manages clinical operational plan and incorporates the study and scientific plan into operational activities. Interacts with the CRO and clinical sites to oversee execution of the clinical trial(s). Ensures compliance with Good Clinical Practices, ICH requirements and regional regulatory requirements and guidelines. Expected to develop contingency plans for ensuring clinical trial timelines and key deliverables are met.
1. Oversee CRO/vendors to ensure overall study plan remains on track. Primary reviewer and content owner of CRO/vendor operational plans (Project Management Plan, Clinical Monitoring Plan, TMF plan, Recruitment Plan, Risk Management Plan). Secondary reviewer of non-operational plans (DM plans, edit checks, safety monitoring plans).
2. Primary responsibility for day to day study activities from start-up to close-out. Communicate Anavex’s expectations regarding study execution to vendors, CROs and sites. Work with CRO counterpart(s) and CRO team (s) to ensure quality study conduct, support issue escalation and drive issue resolution.
3. Develop and follow key metrics for study progress and provide reports to clinical study team/management. Must have good working knowledge of study systems (IxRS, EDC, CTMS, and others as required).
4. Cross-functional point person for key study activities. Engage with other functional groups including Project Management, Clinical, Data Management, Safety and Biometrics to ensure alignment around key study activities.
5. Review of monitoring reports and monitoring calendar to ensure compliance with study review requirements, compliance with CRO CMP and for identification of issues and trends.
6. Responsible for identification and escalation of issues that may impact timelines, budget and/or quality to manager. Drive or support mitigation planning and risk assessment to resolve issues in a timely manner.
7. Provide direction and support to junior team members such as Clinical Trial Associates or CRAs where required.
Other Cross Functional Dependencies
Liaises with the entire cross functional team, and leads team discussions/activities. Works closely with Data Management on data cleaning, locking and planning activities. Works closely with Clinical Supplies to ensure site level drug management.
Bachelor’s Degree in Life Sciences
5+ years experience in clinical or data operations either at the sponsor or CRO
Up to 15% travel
Specialized knowledge, Licenses, etc.:
Knowledge of federal regulations and guidelines, and good clinical practices applicable for the start-up, conduct, analysis, and reporting of clinical trials. Experience with and knowledge of clinical tools such as IxRS, EDC, CTMS and eTMF.
Excellent communication, organization and presentation skills, and the ability to plan, direct, and coordinate a variety of projects. Acts independently in the planning and execution of a variety of projects. Recommends solutions/procedures relating to issues that fall within the boundaries of Anavex policies and procedures as well as the federal regulations and guidelines applicable to the design, conduct, analysis, and reporting of clinical trials.
Job Type: Full-time
- Clinical Trials: 5 years (Required)
- Health insurance
- Dental insurance
- Vision insurance
- Retirement plan
- Paid time off