Senior Clinical Program Manager / Clinical Project Lead

Senior Clinical Program Manager / Clinical Project Lead

Boston, Ma

 

Prerequisites

BA/BS or equivalent degree in life sciences or allied health field At least 10 years of experience in clinical operations roles, including at least 3 years of multi-national experience. Line management experience required.
Responsibilities
Summary/Scope  • The Clinical Trial Manager, Clinical Operations is responsible for overseeing study management as well as the management of the CRO .

Responsibilities may include, but are not limited to, the following: Program / Study Oversight Oversee CRO  study management personnel to ensure timely delivery of high quality project deliverables, including: • Overall strategic management for the planning, execution and reporting of multiple clinical studies / programs (phase I –III) needed to support INDs, NDAs, MAAs • Interact with CRO Study Teams to ensure consistent performance and quality of work. • Ability to work cross functionally as required to appropriately resource study teams. • Strategically assess metrics and ensure implementation of appropriate measures as necessary to support project or program targets / deliverables. Interact with other departments as well as cross-functional teams (i.e.  Clinical Development Teams, Project Teams) at CRO and In-house , to ensure timely delivery of high quality project deliverables, including: • Represent Clinical Operations on assigned Clinical Development and Project Teams • Identify and recommend solutions to problems and/or issues with personnel and/or processes across departments. • Provide specific project / study support and operational input • Work with associated department management in implementing processes to streamline the delivery of study requirements. Therapeutic / Study Input / Guidance: • Provide indication specific and operational guidance when needed • Strategic consulting in relation to projects / studies • Assess and evaluate studies / processes and support implementation and formulation of appropriate plans for action • Participate in vendor selection and review process • Identify new process opportunities, drive and support process improvement initiatives and work with appropriate personnel to implement and re-evaluate processes Budget & Resourcing Budget & Resource Management: • Support the planning and oversee management of the CRO project/study budget and specifications to ensure project/study goals are achieved according to expectations. • Oversight of vendor and site contracts and change order process with  CRO study manager, outsourcing management and finance rep. • Work within the matrix management system to assure study priorities are satisfied and budgets are within scope. • Support identification and issue resolution of budget and resourcing issues related to studies. • Ensure that tracking, financial and resourcing tools are effectively utilized and maintained

Responsible for overall performance management of CRO personnel, including: • Oversee personnel and assure adherence to GCP/ ICP  and SOPs/WPs requirements for studies •   Identify and address performance issues and training needs. Provide guidance and support to direct reports as needed, including: • Serve as a resource and mentor. • Oversee training and documentation of requirements • Provide study / project specific mentoring on operational issues where appropriate. • Provide guidance regarding company policies and procedures. Skills/Knowledge Required: § Experienced clinical R& D professional with knowledge of industry trends and experience in leading and driving operational programs and initiatives § Line management skills and expertise / mentoring and coaching § Disease / therapeutic knowledge / expertise highly desirable § Financial forecasting and budgeting skills & resourcing skills § Excellent oral / written / presentation – communications skills § Solid knowledge of ICH/GCP,  regulatory guidelines/directives and drug development process § Leadership skills / negotiation skills § Effective teamwork and teambuilding skills transferable across functional levels § Time management – ability to effectively multi-task and prioritize in matrix environment § Cross functional and cross-cultural awareness • Make Sound Decisions:  Makes timely decisions based on accurate logic; looks beyond symptoms to identify causes of problems; makes decisions in the face of uncertainty; takes all important issues into account when making decisions. • Act Strategically: Balances big-picture concerns with day-to-day activities; stays informed about industry practices and new developments; understands the organization’s mission and strategies. • Planning: Develops short and long-range plans that are appropriately comprehensive, realistic and effective in meeting goals; integrates planning efforts across work units. • Displays Organizational Savvy: Develops effective give and take relationships with others; understands the agenda and perspectives of others; recognizes and effectively balances the interest and needs of one’s own group with those of the broader organization. • Commitment to Quality: Emphasizes the need to deliver quality products and/or services; defines standards for quality and evaluates products, processes and/or services against those standards; manages quality. • Recognizes Global Implications:  Seeks to understand issues, trends and perspectives of various cultures and countries; recognizes that what works in one’s own country will not necessarily work in another; addresses cultural and geographic differences in strategies and approaches. • Analysis of Issues: Gathers relevant information systematically; considers a broad range of issues or factors; grasps complexities and perceives relationships among problems or issues; seeks input from others; uses accurate logic in analyses.