This position is responsible for key tasks related to site management, territory development, and country study support. It plays a critical role in the local Global Clinical Trial Operations (GCTO) country management team and supports the country or cluster Clinical Research Director or Region Head in executing the Global Clinical Trial Operations strategy in the territory. The position will directly impact the country, cluster, or region's ability to reach business targets and objectives.
Under the oversight of the Clinical Research Director or Region Head, the individual is responsible for monitoring resource management, capacity assessments of the Clinical Research Associate workload, and the overall quality of monitoring deliverables. The role has between three and twelve direct reports (Clinical Research Associate Managers) and indirect oversight of forty to one hundred fifty Clinical Research Associates.
As a line manager, your role is critical in developing key talents in the organization to ensure a pool of success in critical roles. The individual is expected to ensure excellent study performance with strict adherence to local regulations, standard operating procedures, and International Council for Harmonisation Good Clinical Practice guidelines (ICH GCP). Additionally, the individual will collaborate at the local level internally with the Country Therapeutic Area director, Monitoring Excellence, Vendor Management, and can represent the Clinical Research Director in local management if required. Externally, the role involves collaboration with investigators, functional resourcing vendors, regulators, and the pharmaceutical industry.
Responsibilities include, but are not limited to:
Responsible for managing country or cluster monitoring resource management, conducting capacity assessments of Clinical Research Associate workload, and ensuring the overall quality of monitoring deliverables from the area across all projects and monitoring resources (our company's and also partners).
Accountable for resource and talent management of the organization's Clinical Research Associates and Clinical Research Associate managers in the territory.
Collaborating internally with Country Therapeutic Area Directors, Clinical Research Directors, Clinical Research Associate managers, Monitoring Excellence, Vendor Management, and Vendor Strategy to develop and build the territory of principal investigators and sites.
Collaborating externally with investigators, functional resourcing vendors, regulators, and the pharmaceutical industry.
Overseeing and managing local vendors and partners to ensure consistency across the country monitoring organization.
In conjunction with Monitoring Excellence, developing monitoring resourcing strategies in the country or cluster with vendors and Clinical Research Directors to meet current and future resource demands.
Working with vendors to position and place Clinical Research Associates for optimal efficacy and effectiveness.
Being accountable for the overall oversight of all Functional Service Provider Clinical Research Associates.
Collaborating and working closely with other Global Clinical Trial Operations management roles, headquarters teams, quality compliance, finance, information technology, and human resources.
Being a member of the local Leadership Team for Global Clinical Trial Operations and working closely with the country or cluster Leadership team, sponsors, and supporting strategic initiatives across Global Clinical Development and Global Clinical Trial Operations.
This position and its direct reports significantly impact the ability to effectively conduct clinical studies and develop the pipeline while maintaining regulatory requirements and compliance. The individual will directly influence the country's ability to meet business targets and objectives while building productive collaborations with both internal and external business partners.
CORE Competency Expectations:
Business and financial acumen
Strategic thinking
Ability to think cross-functionally and work across boundaries internationally
Early identification of problems, conflicts, and opportunities, with the ability to lead, analyze mitigation plans, and drive conflict resolution.
Fluency in the local language and proficiency in English (both verbal and written), along with excellent communication skills.
Strong knowledge of International Council for Harmonisation Good Clinical Practice (ICH-GCP) and Good Documentation Practices.
Good understanding of global, country, and regional clinical research guidelines and the ability to operate within these guidelines.
Metrics development and management
Behavioural Competency Expectations:
High emotional intelligence
Strong leadership and negotiation skills
Proven success in managing people.
Early identification of problems, conflicts, and opportunities, with the ability to lead, analyze, and prepare mitigation plans and drive conflict resolution.
Demonstrated ability to build relationships with senior business executives
Influencing skills
Excellent interpersonal and communication skills, including conflict management.
Strong relationship management and networking skills, with a solid integration into both local and headquarters therapeutic area networks.
Effective time management.
Effective communication with external customers (such as sites and investigators).
Experience Requirements:
A minimum of twelve years of experience within the pharmaceutical industry.
A minimum of ten years of experience in clinical trial organization.
A minimum of five years of experience in a functional management position.
Advantageous:
Experience as a Clinical Research Associate.
Management of Clinical Research Associates and familiarity with outsourcing and flexible resourcing models.
Educational Requirements:
Bachelor's degree in science or equivalent healthcare experience. Advantageous: An advanced degree (for example, Doctor of Medicine, Doctor of Philosophy, Doctor of Pharmacy, Master of Science).
This position is a regular employee status.
Search Firm Representatives Please Read Carefully:Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place.
Job Posting End Date: 11/23/2024
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