Merck Head of Clinical Trial Operations - #NCP1 in Kenilworth, New Jersey
Global Clinical Trial Operations (GCTO) is critical organization in the Research & Development (R&D) Strategic Operations organization. GCTO works closely with various stakeholders to ensure the flawless execution of the company's clinical trials. GCTO provides oversight and management of all operational aspects and execution of all clinical studies. GCTO has global accountability for selection and oversight of all external CRO and BPO activities.
Reports toSVP,R&D Strategic Operations
CRO & BPO capabilities located around the world.
Annual operating and capital budget: $25M - $50M
TheAVP GlobalHead ofGlobalClinical Trial Operationswill manage FTEs and CRO / BPO capabilities.
The Associate Vice President of Global Clinical Trial Operations leads a team that is accountable for the planning and execution of all clinical trials. The AVP will drive an integrated operational vision and strategy that facilitates quality and efficiency across all clinical trials. This position partners closely with other R&D Strategic Operations team members to support and execute against the company's and R&D's strategic priorities.
The responsibilities for the position is as follows:
Provide strategic direction for outsourcing, oversight and experience in CRO and vendor selection
Envision and drive innovative business models for clinical trial execution and oversight
Leads and partners in the development and presentation of clinical operational strategy to executive leadership
Partner closely withpeers on the R&D Strategic Operations Leadership Team to ensure tight integration of business processes and digital tools across the drug development continuum
Oversee technical expertise for the development of clinical trial documents and trial conduct and vendor management.
Ensure the quality and compliance of the company'sclinical trials.
Collaborate with the Clinical Development, Regulatory and Project Team leadership as well as Biostatistics, Medical Writing, and Drug Safety to assure integration of clinical trial delivery, including identifying and mitigating issues as they arise to ensure timely and on-budget execution.
Responsible for implementation and execution of the global operational clinical studies strategy.
Collaborates cross‐functionally on due‐diligence efforts and assessments for mergers,acquisitions, and collaborations.
Collaborates with regulatory, medical affairs and commercial to assist with life cycle management of approved drug products.
Ensure consistency, quality and compliance in Clinical Operations including establishing/revising SOPs, standards, templates and tools necessary to ensure timely, efficient and high-quality clinical trial deliverables.
Oversee the preparation and management of clinical trial budgets and timelines and trial related metrics to drive corporate goals in a time efficient manner
Demonstrated excellent decision-making ability with competency in making decisions and resolving problems. Ability to recognize which decisions may have a consequential effect onthe Project and/or Study and to make decisions based on experience, skill, and situation, consulting with and/or informing others as appropriate.
Provide direction and mentorship to staff including setting goals that are aligned with both Corporate and project goals
Proven ability to foster team productivity, cohesiveness, and collaboration with a results-oriented leadership style to drive
Excellent communication/interaction skills and experience in a dynamic and growing organization.
Ability to handle multiple competing priorities to meet deadlines in a dynamic environment.
Evaluate activities and business processes, identify areas in need of improvement and take the lead in investigating potential solutions or new ways of working
- Master’sDegree or PhD
15 years effectively leading and managing the global clinical operations function in the execution of all phases of global clinical trials (Phases 1 through 4)
Successful experience in executing clinical trials inaninnovativeoutsourced clinical trial operations environment.
Demonstrated commitment to quality and compliance.
Demonstrated enterprise mindsetthat extends beyond the management of clinical trials.
Track record ofinnovation in business process and digital in the clinical operations space.
Expertise in the areas of global drug development, planning, management and execution of clinical trial operations
Strategic thinker and problem-solver capable of identifying risks and risk mitigation strategies.
Demonstrated knowledge of and collaboration with clinical data management for efficient planning of study monitoring, data collection and cleaning resulting in high quality data for analysis within agreed DB lock timelines.
Demonstrated experience managing and mentoring clinical operations team members including negotiation and influencing skills while establishing clear and consistent goals and objectives
Demonstrated knowledge of international clinical pharmaceutical standards including, ICH/GCP guidelines, and regulatory compliance in multiple countries and regions.
Excellent written and verbal communication skills.
US and Puerto Rico Residents Only:
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Flexible Work Arrangements:
Valid Driving License:
Number of Openings:
Requisition ID: R61027
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