Clinical Program Manager/Sr. Clinical Program Manager (CPM)

Job Summary:

 In this role, you will have the opportunity to work independently and collaboratively in an exciting young company.   The Clinical Program Manager (CPM) is accountable for leading day-to-day operations of one or more clinical studies, ensuring efficient delivery of clinical trials in a matrix environment. This role is responsible for working with and leading selected vendors in the execution of the clinical trials assigned. This position will report to a Clinical Program Director.  This position is remote or in-house, depending on prior experience.  Any in-house positions for this role will begin home-based until offices are opened to normal operating procedures.

Responsibilities:

• Lead cross functional study management team to ensure effective planning, implementation and execution of clinical trials within agreed timelines, resources and budget
• Facilitate operational activities pertaining to the execution of Ph I-IV clinical trials from study start through close-out
• Primary contact for functional area representatives and vendors responsible for protocol execution
• Provide oversight of internal clinical operations team members, CROs, service providers and consultants that are involved in assigned studies
• May assist in the development and review of Investigator Brochure, study protocols, case report forms, and clinical study reports
• Development and review of informed consent forms, study plans, study materials and tools
• Establishes study milestones and ensures accurate tracking and reporting of study progress
• Preparation of study budgets and timelines
• Ensure studies are managed and executed in accordance with ICH GCP, regulations, the protocol, and company SOPs
• May conduct site visits (in conjunction with CRO, if applicable) for oversight, site evaluation, initiation, monitoring, or close-out activities
• Participate and respond to Quality Assurance and regulatory authority inspection audits
• Participating in service provider selection process as a part of outsourcing activities
• Responsible for selection and study specific training of CRO study staff, monitors, investigational sites, and service providers
• Plan and coordinate Investigator Meetings
• Recommends and implements innovative ideas to increase efficiency and quality of study management activities
• Mentoring junior team members

 Qualifications:

• Bachelor’s degree, preferably in a scientific field
• Minimum of 7+ years of related industry experience in the pharmaceutical industry or equivalent, with 5+ years of study management experience at a Sponsor or CRO, recent oncology experience required
• Proven ability to lead a study team
• Excellent communication skills both verbal and written are required
• Flexibility and willingness to step in and be a team player
• Strong problem-solving skills with the ability to focus on time-sensitive objectives.

Skills/Abilities:

• Thorough understanding of ICH GCP guidelines
• Familiar with advanced concepts of clinical research and experience in driving execution, from study start-up through study closure, (e.g., data management, safety, biostatistics, medical writing)
• Self-motivated, assertive, and able to function independently and as part of a team
• Effective in selection of investigative sites, CROs, and vendors and management of external resources
• Strong interpersonal and negotiation skills as well as strong verbal and written communication (including presentation of materials to internal teams and external partners)
• Proven problem solving and decision-making skills
• Excellent planning and organization skills
• May have line management responsibilities
• Excellent IT Microsoft skills and experience using clinical trial management web-based systems (i.e. EDC, IRT, CTMS, eTMF, etc.)
• Ability and willingness to travel 10-20% (domestic and international)