Senior Clinical Project Manager

Role Summary

The Senior Clinical Project Manager is responsible for overseeing and managing trials within clinical programs. This includes management and oversight of CROs and other service providers. The Senior CPM is responsible for planning, organizing, and directing the completion of trials on time, on budget, and within scope. This includes overall workload and clinical management of the trials in partnership with other functional areas.

Responsibilities

• Assist with development of the protocol and informed consent form and/or program design
• Master the basic elements of the study protocol, investigator brochure, informed consent forms, and study specific materials
• Evaluate and qualify CRO's/vendors/investigator sites in a systematic and organized fashion
• Negotiate budgets and contracts; effectively communicate with third party vendors
• Lead regularly scheduled project meetings or ad-hoc discussions with an agenda for tracking meeting minutes and action items
• Manage vendor budgets, payments, and timelines
• Coordinate with all relevant study team members to ensure studies progress on time and on budget
• Effectively track and report on internal project metrics and study progress
• Responsible for the registration and maintenance of the clinical trial design, status, and results as required by clinicaltrials.gov
• Prepare, review, and approve study plans and manuals for study start up
• Develop recruitment plans and materials; collaborate with recruitment vendors
• Plan Investigator Meetings [such as attendee travel, accommodations, meeting schedule, presentations, etc.] and adhere to the set budget and timeline
• Communicate study procedures, methods, and expectations to all parties
• Assure delivery and/or return of required study supplies (IP, lab supplies, etc.) to/from sites
• Oversee and approve site regulatory packages for initial drug shipments
• Attend or lead monitoring and co-monitoring visits
• Oversee data cleaning; track the issuing and resolution of data queries
• Manage design and development of eCRFs, electronic data systems including database locks
• Maintain inspection ready TMF, familiarity with TMF reference model
• Contribute to clinical study report writing and review
• Follow all established occupational health and safety procedures, good clinical practice (GCP) and standard operating procedures (SOPs)
• Oversee work of junior staff by providing guidance and constructive feedback
• Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork

Skills

• Detail oriented and organized, and adept at data entry, reporting and maintaining comprehensive records
• High level of professionalism, including meeting-presence & etiquette
• Strong communication skills (both verbal and written), able to communicate with executives and staff
• Demonstrated ability to protect and maintain confidential and personally identifiable information
• Strong knowledge of ICH GCPs
• Advanced level proficiency in Microsoft Office products. Experience with Office 365 and SharePoint is a plus
• Willingness to learn and navigate challenges, identify a resolution and be accountable for assigned tasks
• Strong experience with clinical trial systems (EDC, TMF, CTMS, IRT systems)
• Demonstrates a high level of problem-solving skills with little to no guidance
• Ability to mentor junior staff on tasks assigned for projects, and begin to develop people management skills
• Ability to travel up to 25%, more during peak periods (e.g. site selection and initiation)
• Ability to work independently with minimal supervision

Education

• Bachelor's degree in life sciences or related field; advanced degree highly desirable

Experience

• Minimum 8 years in clinical operations or research with increasing levels of responsibility (e.g. clinical trial manager, clinical trial associate, clinical research coordinator, clinical research associate).
• Minimum 4 years managing clinical projects, ideally from start to end of a trial.