Clinical Program Manager

Clinical Program Manager

Leads the cross-functional execution of one or more clinical studies conducted within the Clinical Research Unit (CRU). Accountable to CRU leadership and the Core Study Team for delivery of a CRU study according to agreed quality, timeline and cost parameters. Assures that CRU studies are conducted in compliance with GCP, relevant SOPs and local regulatory requirements. Assures data integrity and data quality for each assigned study through input to study feasibility and protocol development efforts, verification of EDCMS study set up, management of cross-study activities and coordination of CRU functional line data review/verification activities (e.g., data verification, data cache review, data listing reviews, study report reviews). Coordinates and contributes to the assessment and minimization of operational risks and to the resolution of operational issues. Promotes best practices within and across CRU studies to drive operational excellence.

Responsibilities include:

• Responsible for study/project management within the unit including study scheduling, protocol planning (start-up activity) and is the primary contact for the project teams responsible for the compound/project - from the time of the Study/project document is drafted until the data base/project is locked
• Leads CRU cross-functional input to, and review of, the Study Protocol prior to finalization
• Serves as primary liaison/point of contact for the Core Project Teams/Clinical Research Unit (CRU)
• Develops and ensures adherence to study timelines
• Coordinates and reviews all study activities
• Serves as primary point of contact for on study decisions related to the protocol, data collection and volunteer activities
• Partners with line leaders and functional staff across CRU departments
• Maintains accuracy, accessibility and confidentiality of all volunteer records and reports o In depth review of all clinical data, serves as study monitor, ensures all data is complete and checked before database lock and release
• Leads the data integrity/data quality activities for assigned protocols
• Reviews Informed Consent Document for IRB submission
• Provides critical assessment of strategic partner and vendor proposals to ensure study success
• Reviews site level clinical trial budget
• Leads other functions and strategic partners to ensure timely delivery of quality data
• Oversees the overall execution of clinical studies
• Participates in study meeting with relevant partners for operational alignment
• Communicates opportunities and risks to the Core Project Teams for integration in risk management plans
• Effectively coordinates all functional areas involved in clinical trials to solve problems and assure progress and timely completion of study goals
• Responsible for ensuring clinical trials are conducted in accordance with scientific, medical, and ethical principles, and within regulatory requirements/guidelines
• Responsible for volunteer safety and accurate interpretation and execution of research protocols including multiple study activities
• Leads the clinical study components with respect to time, operational feasibility, and study-level CRU resources required to deliver individual studies against the development plan (part of the study budget)
• Assesses impact of technologies required to deliver clinical trials and incorporates the development of these technologies into the clinical studies to ensure conduct and data collection suitable for purpose
• Provides support for Methodology/Mechanistic studies as appropriate
• Partners with Core Project Teams to provide study schedule and budget information to enable project management
• Identifies performance/quality issues to develop appropriate remediation plan
• Identifies and escalates system or process issues affecting deliverables
• Manages the creation and detailing of all study activity/source documents
• Leads the quality control of all study related activities for assigned protocols
• Assures data integrity and data quality in assigned studies
• Accountable to CRU leadership for the highest quality of data in clinical trials
• Manages all data queries specific to subject data collection
• Supports EDCMS setup; assures EDCMS Setup reflects requirements of final approved protocol or approved amendment(s) Assures staff perform necessary data quality and review checks
• Reviews data output over the course of the study and escalates any noted issues to the appropriate staff member or line leader
• Leads a systematic review of all study data prior to database lock to assure the absence of data issues
• May represent the unit on Global initiatives (Global SOP's, process improvement teams, other activities as they present themselves) as they are the subject matter experts in the Unit
• May Lead CRU teams in accomplishing business needs and resolving issues
• May represent the CRU as a subject matter expert for internal/external resource (provide support to external centre, etc.)
• Participate in study and staff scheduling for assigned protocols, as appropriate
• May participate in study related data collection activities as needed
• Oversee creation and detailing of study activity documents for staff & volunteer use
• May mentor/coach other staff

Qualifications

Minimum of BA/BS in a biomedical discipline or equivalent education/training is required; advanced training/education preferred. Relevant experience in clinical research and drug development with clinical operations experience required. Specific direct experience in early drug development (Phase I and IIa) preferred. Substantial clinical operations and pharmaceutical industry experience in order to have a thorough understanding of the processes associated with executing clinical development plans and addressing related regulatory issues. Experience in Project Management and leadership of matrix teams is essential. Drug development experience including familiarity with: Clinical study management and monitoring, Project/process management, Data management, Clinical & regulatory processes, Regulatory submissions, Budget / expense management, Experience of Vendor Management, Scientific excellence, Administrative excellence, Systems technology. Initiating and Implementing Change: Innovation, Learning Organization, Flexibility and Resilience, Courage with Decisiveness to Act, Problem Solving, Positive approach, forward thinking, challenge the status quo. Matrix leadership skills: Influencing, Collaborative, supportive, Networking and Alliance Building, Personal Leadership, Team work, Communication, Negotiation, Decisive and assertive, Change agile, Able to deal with ambiguity. Proficiency in using MS Office tools suite (Excel, Word, etc.)