Responsible for bringing people, processes & technology together to generate business value. Contribute to clinical study life cycle through precision, speed and innovation. Accountability includes: providing study start-up, conduct and close-out support through system specification, data review, and query management; providing key technology and process support to internal personnel and investigative sites with the goal of optimizing our eClinical system and process portfolio; providing global sample management support for Pharmacokinetics, Pharmacodynamics, & Pharmacogenetics samples with an emphasis on planning, standardization and production throughput; and finally, bringing clinical trial data through the steps of extraction, transformation and loading into internally-developed clinical databases through the use of innovative systems and processes, and a focus on standards to present data in a usable format for Global Pharmaceutical R&D.
Key Responsibilities Includes :
- Oversee the production of all Data Sciences timelines and deliverables for assigned clinical trials and all DSS-related cross-functional meetings with clinical teams, safety teams and physicians
- Oversee all EDC,and IRT vendor contracts for assigned clinical trials
- Supervise all Data Sciences staff (including equivalent CRO staff) for assigned clinical trials
- Co-represent Data and Statistical Sciences at any meetings with FDA and regulatory agencies regarding assigned clinical trials
- Lead clinical study team in the development of key clinical trial systems, study conduct and study close-out as related to Data and Statistical Sciences (DSS) operational activities. Create and manage Data Sciences communications plan for all assigned clinical trials. Exercises real, but informal authority over Data Sciences study team members' daily tasks and timelines.
- Manages 4 to 7 clinical trial startups concurrently
- Plan and manage all Data Sciences timelines and deliverables for assigned clinical trials
- Complete trial-specific Statement of Work (SoW) based on parameters supplied by Master Service Agreement (MSA) for Electronic Data Capture (EDC), electronic Patient Reported Outcomes (ePRO) and Interactive
- Response Technology (IRT) vendors for assigned clinical trials
- Manage and maintain vendor budgets for assigned clinical trials and process flows and data exchanges with global pharmacovigilance for clinical trial serious adverse events.
- Manage any internal quality assurance audit for assigned clinical trials
- Bachelor's (Master's preferred) degree in business, management information systems, computer science, life sciences or equivalent
- 5 to 8 years of direct clinical development experience. 2+ years of clinical development management. Phase II and III experience
- Demonstrated strong leadership competencies with broad business orientation and experience in leading teams in the management and completion of clinical trials
- Proven track record of successful studies (delivered on time, within budget, and with high quality)
- Recognized leader in process development (SOPs, Global Regulations, OEC, Outsourcing) and the application of procedures to the business. Recognized as a leader and key contributor to initiatives and advancement of DSS as an organization
- Knowledgeable in the end-to-end clinical systems development cycle
- Demonstrated effective communication skills
- Ability to develop advanced knowledge of major concepts of key systems
- Builds strong relationships with peers and cross functionally with partners outside of team to enable higher performance. Creates a learning environment, opens to suggestions and experimentation for improvement. Embraces the ideas of others, nurtures innovation and manages innovation to reality.
- Learns fast, grasps the 'essence' and can change the course quickly where indicated. Raises the bar and is never satisfied with the status quo
Equal Opportunity Employer Minorities/Women/Veterans/Disabled