Senior Clinical Project Manager

Role Summary

The Senior Clinical Project Manager is responsible for the overall management and coordination of operational activities involved in the planning, conduct and completion of clinical trials, including management of deliverables, budget adherence, and ongoing risk mitigation. Manages selected CROs and leads cross-functional project teams to ensure on-time, within-budget delivery of high quality trials.

Responsibilities

• Drive the planning, development, and execution of timelines while identifying and tracking the team’s critical path.
• Facilitate the project team kick-off meeting by identifying key stakeholders and resources.
• Execute and control project activities, including scope, schedule, budget, and risk, and report performance to senior management.
• Establish communication plans for information distribution to team members.
• Manage project/program meetings.
• Conduct project/program reviews at significant milestones or gates to evaluate successes against baseline estimates.
• Integrate understanding of constraints across and within projects and recommend alternatives.
• Identify and track key study metrics to identify/anticipate issues and conduct root-cause investigations for issue resolution or escalation.
• Assist the scientific staff in developing and reviewing protocols, investigator brochures, informed consent forms, clinical study reports and other scientific documents.
• Assist with regulatory submission preparations.
• Author/oversee the development of plans related to project management, site monitoring, safety management, data management and biostatistics.
• Identify, evaluate, and select external vendors (central lab, CROs, consultants/contractors).
• Train and manage CROs and other clinical vendor activities to ensure quality meets regulatory requirements.
• Perform periodic visits to sites and/or CROs to assess progress and compliance; develop/review/approve study plans.
• Develop contracts for and manage vendors to ensure deliverables and performance meet contract terms.
• Oversee the initiation of sites and identification/selection of sites.
• Develop patient recruitment strategies to meet enrollment goals.
• Oversee development of CRFs, clinical databases, safety databases, and shell Tables, Figures and Listings.
• Plan, coordinate, and conduct investigator meetings.
• Contribute to planning, coordination and conduct of Data Monitoring Committee (DMC) meetings.
• With Medical and Safety, assess trends in data including adverse events and protocol violations.
• Oversee timely database freeze and database lock; participate in data review meetings.
• Oversee maintenance of the Trial Master File and archival processes.
• Ensure adherence to SOPs, GCP and ICH regulations.

Qualifications

• Bachelor’s degree or equivalent in the life sciences or related field; additional coursework or certifications in clinical trial planning and operations desirable.
• At least 5 years of experience as a global clinical project manager.
• Experience in rare diseases preferred.
• Experience working in a fully outsourced model.
• Experience in small, fast-paced biotech is a plus.
• Experience coordinating interdepartmental activities to meet protocol and program goals.
• Extensive knowledge of CRO/vendor management and global protocol operations.

Skills

• Working knowledge of GCP, ICH guidelines, and regulations.
• Proficiency in resource planning and clinical trial budgeting.
• Ability to manage multiple priorities with aggressive timelines.
• Strong oral and written communication skills.
• Strong interpersonal skills to build relationships with investigators, site staff, and CROs.
• Ability to work with minimal supervision, take initiative, meet deadlines, and resolve/escalate problems timely.
• Ability to develop creative solutions to issues impacting timelines and budgets.

Education

• Bachelor’s degree or equivalent in the life sciences or related field. Additional coursework or certifications in clinical trial planning and operations desirable.

Additional Requirements

• Willingness and ability to travel domestically and internationally; expected travel about 10% of work time.