(Senior) Clinical Program Manager

 

Our client is a biopharmaceutical organization looking for some TOP clinical talent to be part of their new clinical operations team to assist in moving from Phase 2 to Phase 3 trials in a variety of therapeutic areas. If you are looking to join one of the top international firms and participate in some exciting areas of clinical research, please take a look…

 

Responsibilities:

 

·  Lead and manage the strategic implementation of regional/global studies and/or programs within and across therapeutic areas

·  Is the representative and single point of contact on at least 1 program teams where each team is responsible for multiple studies

·  Represents regional Clinical Operations on global initiatives

·  Represents Clinical Operations in the matrix bodies within clinical development

·  Participate in regional or global matrix teams to ensure implementation of relevant planning strategies

·  Up to 6 direct reports (for Sr. CPM) and functional reports

·  Working in a Matrix Team (Environment): Co-chairing multi-functional project/program teams

·  Mentoring/Leading diverse program teams

·  Establish and maintain program relationships with CROs and other vendors·  Review end-of-program learning debriefs and advise across clinical operations·  Proactively identify issues, propose and implement risk management strategy to manage implications upon program timelines and goals

·  Review and approve  timelines and study conduct plans

·  Review and approve forecasting

·  Review and approve country/site start up and patient recruitment plans developed internally or by CRO

·  Assist in the identification, recruitment, and mentoring of key talent within Clinical Operations·  Assure the quality of deliverables

·  Advise on resourcing solutions for studies and develop ability to estimate number of internal and external FTEs required for studies

·  Budgets: Track and report on study spend to targets

·  Accountable for budgets up to $15  million in external study spend across multiple studies

 

Requirements:

 

·  Bachelor’s degree in Science or Health-related preferred

·  5-6 years experience for CPM, 7-8 years experience for Sr. CPM in Clinical Study Management or equivalent management experience

·  Proven track record to deliver key process initiatives for operational strategies

·  Advanced understanding of R&D and drug development process such that the employee is able recommend, influence, and implement improvements to the process

·  Is able to interpret impact of the external regulatory environment on Study Management, independently formulate strategy to react, and implement

·  Advanced understanding of clinical practices

·  Has advanced managerial skills and can effectively manage daily and routine situations independently