Description
Position Summary- Initiates and manages all operational study activities (from feasibility to database lock) and serves as Primary point of contact for the Core Project teams.
- Translates protocol/project strategies from a concept into an executable study/project
- Focuses on the operational integrity and feasibility of individual studies utilizing a variety of resource solutions to ensure the most effective, efficient, and high quality study/project is designed and executed
- Participates in and influences the operational strategy for study/project delivery including milestone deliverables to optimize use of time, cost and resources
- Participates in the identification, assessment and mitigation of risks at the study level
- Maintains continuous communication between partner lines, strategic partners, contractors and vendors
- Optimize Operational Control and Effectiveness
- Assures close partnership with study investigators to assure successful study delivery and high quality data
- Fosters positive community attitudes and volunteer trust through professional behavior and ongoing communication.
- Responsible for study/project management within the unit including study scheduling, protocol planning(start up activity) and will be the primary contact for the project teams responsible for the compound/project - form the time of the Study/project document is drafted until the data base/project is locked.
- Create and ensure adherence to study timelines
- Supervises initiation and monitoring of all study activities
- Primary point of contact for on study decisions related to the protocol, data collection and volunteer activities
- Partners with different departments
- Maintains accuracy, accessibility and confidentiality of all volunteer records and reports
- Monitors and summarizes clinical data
- Evaluates and may identify new equipment/technologies/vendors
- Lead the data management activities for assigned protocols
- Initiate Inform Consent Document for IRB submission
- 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
- Contributes to the clinical study components with respect to time, operational feasibility, and study-level 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
- Oversees the creation and detailing of study activity/source documents.
- Supervises/Monitor the initiation and quality control of all study related activities for assigned protocols
- Initiates and manages all operational study activities:
- Provides critical operational and feasibility input to study design
- Contributes to the protocol development
- Aligns and influences study level operational strategies across programs and partner lines
- Provides critical assessment of strategic partner and vendor proposals to ensure study success
- Ensures appropriate level of oversight is maintained utilizing escalation plans and providing resolution to issues at the study level
- Forecasts site level clinical trial budget
- Works proactively with other functions and strategic partners for 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
- Anticipates potential problems within a clinical trial and creates contingency plans accordingly
- Mentor and coach other clinic personnel as needed
- Initiate general staff training activities
- Lead data management: Manages all queries specific to subject data collection, supports EDCMS setup/QC activities.
- 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 teams in accomplishing business needs and resolving issues
- May represent the 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 and volunteer use
EDUCATION AND EXPERIENCE
- At least 5 years relevant experience in clinical research and drug development with clinical operations experience. Preferably with first Experience in early drug development (Phase I and IIa)
- 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
- Ease in using office tools suite (xls, word, etc ) MS Excel