Description
Summary:- Leads the cross-functional execution of one or more clinical studies conducted
- Accountable to PCRU leadership and the Core Study Team for delivery of a PCRU study according to agreed quality, timeline and cost parameters
- Assures that PCRU 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 PCRU functional line data review/verification activities (eg, 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 PCRU studies to drive operational excellence
- 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 PCRU 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 (PCRU)
- 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 PCRU department
- Maintains accuracy, accessibility and confidentiality of all volunteer records and reports
- 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 PCRU 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 PCRU 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 PCRU teams in accomplishing business needs and resolving issues
- May represent the PCRU as a subject matter expert for internal/external resource (provide support to external center, 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 and 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.)