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Position Summary :
The Regional Head of Clinical Operations, Southern and Central Eastern Europe provides site management and monitoring support within the Southern and Central Eastern European region and across the BMS R&D portfolio. This role reports to the Senior Vice President and is a key member of the RCO Leadership Team.
Key Responsibilities
Provides strategic and operational leadership for site management and monitoring conducted within the region across the BMS R&D portfolio.
Accountable to provide significant input, guidance, and direction to global initiatives to ensure that regional perspective and operational implications of proposed changes are considered and managed to.
Identifies needs, directing development and continuous improvement of processes, systems and strategies to support evolution of GDO business operating model with a particular focus on regional operational aspects.
Leads a multi-national team of clinical operations professionals that contribute significantly to BMS portfolio of clinical trials.
Provides ongoing feedback, coaching, and career development, including engagement and retention support to staff to maximize their potential.
Empowers and holds country level clinical trial management to high quality performance and delivery of the business.
Provides overall leadership and guidance across the portfolio that shapes the direction of RCO strategy to assure optimized geographic allocation of resources supported through internal resources & external partnerships, focused attention to site dynamics and needs to assure BMS becomes a favored site partner.
Ensures adaptive management of site monitoring and site management through the effective deployment of resources and streamlined processes, ensuring productivity targets, validity and quality of the data gathered in support of the evolving portfolio of BMS products.
Understands the regulatory environment within the region, providing direction, guidance and support during inspection preparation, sponsor, and site activities.
Represents the Company in key interactions with key external partners.
Serves as a leader across R&D and developing strong and productive working relationships with key stakeholders throughout BMS with the ability to think strategically across a broad portfolio and effectively express his/her views to senior management.
Ensures RCO representation as needed in governance or strategic teams or committees (preparatory materials, direct participation, or representative).
Engages and energizes employees through communication of goals, priorities and other business critical information as well as focus on employee value proposition, development and retention activities.
Develops and promotes a workplace culture that values diversity of thought, promotes integrity and creates an atmosphere that supports coaching and fosters accountability.
Qualifications & Experience
Degree Requirements
- Bachelor's degree required with an advanced degree preferred.
Experience Requirements
At least 10 to 15 years of relevant industry experience, with substantial experience of managing staff in a global setting.
Significant global clinical trial expertise and a successful track record of leading through influence, working across complex, global organizational matrices.
A strong understanding of the drug development process with proven expertise in clinical trial execution and management in a global arena.
Expert in ICH/GCP principles as it relates to clinical trial execution and impact to the business supporting clinical trial execution.
Key Competency Requirements
Demonstrated partnership across various collaborative forums, CROs, SMOs and/or local site networks.
Diverse and sufficient technical expertise to be a credible interface to all global development and business partners (medical, development, commercial, regulatory & quality etc.)
Broad intelligence of the clinical trial environment across key regions, and anticipation of future trends and impact.
Strong influential leadership and communication capabilities with a proven ability to engage, manage, develop and inspire a large, geographically diverse team.
Knowledge, experience and successful interaction with important International Health Authorities.
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