Clinical Study Team Lead - FSP
Parexel International Corporation
USA - Any Region - Home Based
ExecuPharm is the North American clinical operations business within Parexel FSP. We provide biopharmaceutical companies with qualified and talented professionals to accelerate the development and delivery of new therapies.
For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is the CRO trusted by life sciences companies to innovate keeping patients at the center of everything we do, and where an inclusive global community helps you be your best, transforming any career into a life-changing achievement.
• The Clinical Study Team Lead (CSTL), using project management and leadership skills, is responsible for the delivery of one or more clinical studies from study concept through reporting, submission and as needed regulatory defense activities in alignment with the overall program timeline, to cost and quality goals through the matrix leadership of the Study Team(s) • The CSTL is the primary point of contact between the Business Unit (BU) and Clinical Development and Operations (CD&O) • The CSTL is accountable for study delivery • The CSTL leads the Study Team and Project Manages study deliverables through internal (within Development Operations, business unit and other platform lines) and external resources and is the primary point of contact and interface between these functional groups • The CSTL will champion operational excellence to provide continuous improvement of processes and sharing of best practices
Qualifications• Bachelor’s degree or equivalent in one of the disciplines related to life sciences, drug development, project management or business • Advanced degree is desirable. • It is likely that someone suitable for this position would have greater than 5 years of project management or similar discipline • Extensive clinical operations and pharmaceutical business experience in order to have a thorough understanding of the processes associated with executing clinical development plans and addressing related regulatory issues • Leadership, project management, resource management, administrative and technical capabilities are required • Effective verbal and written communication skills are required in relating to customers and colleagues both inside and outside the organization • Knowledge of team development principles and successful implementation required • Experience supporting regulatory submissions highly desired • Drug development experience including familiarity with: o Clinical study management and monitoring o Data management o Clinical & regulatory processes o Regulatory submissions o Project/process management o Budget/expense management o Experience in Vendor Management (preferred) • Knowledge and success in managing multiple clinical studies • Knowledge of Data Management processes, data acquisition and management technologies and processes • Demonstrated knowledge of clinical development and regulatory submission processes and requirements • Demonstrated ability to manage complex projects and processes • Proven track record of effective project management of drug development or other projects in a highly matrixed environment • Required to deliver, time, and cost, quality and risk management to teams • Understands and has demonstrated ability to manage large and complex budget; history of staying on or under budgetEEO DisclaimerParexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.