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-

• 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

• 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.)

Thanks

Regards

Ricky

732-429-1925