Description of Program Lead within Clinical Data Sciences
Data Sciences brings people, processes, and technologies together in support of AbbVie's clinical trials. Our wide range of accountabilities span both clinical and operational domains and include development of clinical systems and management of clinical data, operations and end-user support for both clinical and operational technologies, clinical and operational data analytics, and bio-sample logistics and management.
Primary Job Function
Provide program-level leadership and promote operational excellence ensuring successful execution of Data and Statistical Science (DSS) deliverables.
Position Accountability/ Scope
· Accountable for execution and on-time delivery of planned DSS milestones for clinical technologies from start-up through close-out.
· Drive DSS study team operations and connect with cross-functional study teams to deliver trials and programs.
· Develop and sustain strong relationships between internal stakeholders, external vendors, cross-functional peers, and DSS senior management.
· Synchronize deliverables between DSS, offshore resources, and vendors to deliver outcomes as planned.
· Influential in setting the strategy for Data Sciences (DS).
· Management of operations through metrics. Categories include, but are not limited to, data, systems, general operations, and milestones.
· Reports into the DS Therapeutic Area leader and has accountability for global study planning and execution.
Core Job Responsibilities
· Responsible for program/compound-level timelines, while ensuring compliance and quality.
· Responsible for the oversight of risk mitigation/risk management and contingency plans at a program level for all DSS deliverables.
· Influence and participate in clinical strategy team; including but not limited to protocol development and clinical technologies.
· Set expectations with the DSS team, the clinical study team, DS vendors, TA, and other external teams regarding timelines, processes and general coordination of the program.
· Communicate with confidence and leadership with these groups for prioritizations, actions, and resolutions throughout the life of a program.
· Act as a point of escalation for internal and external issues.
· Lead clinical study team in the development of key clinical trial systems, study conduct and study close-out as related to DSS operational activities.
· Oversee all Data Sciences timelines and metrics for assigned clinical trials.
· Lead DSS-related cross-functional meetings with clinical teams, safety teams and physicians.
· Oversee all vendor contracts for assigned clinical trials including accountability for Statement of Work (SoW) and Change in Scope.
· Participate in DSS-related cross-functional meetings with stakeholders as appropriate.
· Ensure stakeholder confidence in the health of the study by leading meetings to effectively communicate expectations, progress, issues and resolution.
· Partner with Total Quality Management Lead to ensure highest quality of team deliverables.
· Participate in any FDA or other regulatory meetings regarding assigned clinical trials.
· Influence decisions and approaches through effective negotiation.
· Ensure quality assurance as a measure to achieve audit and database lock readiness for assigned clinical trials and programs.
· Accountable for any audit findings regarding process execution or data integrity for any assigned clinical trial.
· Mentor team members.
· Accountable for supporting and utilizing Data Sciences policies and procedures
Position will be hired based on the following:
Bachelor's degree or equivalent is required.
Minimum Experience / Training Required
Must have 5+ years of clinical research related experience (and/or applicable work experience); including 2 years (and/or applicable work experience) in clinical research demonstrating a high level of core, technical and leadership competencies through setting and driving strategy and leading a global program(s). Effective leadership skills with a proven ability to foster team productivity and cohesiveness. Demonstration of successful coaching/ mentoring. Demonstration of successful execution of a program in a fast-paced environment managing multiple priorities effectively.
Equal Opportunity Employer Minorities/Women/Veterans/Disabled