Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.
This position is responsible for key tasks related to site management / monitoring, territory development and country study support. It is a critical role in the USA Global Clinical Trial Operations (GCTO) country management team and supports the US leadership team and North American Region Head in executing GCTO strategy in the territory. The position will directly impact country/cluster/region ability to reach business targets and objectives.
Under the oversight of the Region Head, the person is responsible for monitoring resource management, capacity assessments of Clinical Research Associate (CRA) workload and overall quality of monitoring deliverables. The role has 3 to 12 direct reports (CRA manager) and has indirect oversight of 40 to 150 CRAs. As line manager the role is critical to develop key talents in the organization to ensure a pool of success in critical roles.
The role should ensure excellent study performance with strict adherence to local regulations, our Company Standard Operating Procedures (SOPs) and International Council for Harmonisation Good Clinical Practice (ICH GCP), will collaborate at local level internally with Country directors, Monitoring Excellence, Vendor management. Collaborates externally with Investigators, Functional Resourcing Vendors, regulators and Pharma Industry.
This is a remote-based role that can sit anywhere in the US.
Responsible for country or cluster monitoring resource management, capacity assessments of CRA workload and overall quality of monitoring deliverables from the area across all projects and across all monitoring resources (our Company and partners). Ensure metrics are met at expectations.
Accountable for resource and talent management of CRAs and CRA managers in territory. Manages performance of CRA managers, conducts performance evaluations, encourages high performance to agreed aims and objectives. Addresses low performance situations and ensures development needs are addressed. Ensures CRA managers do the same with CRAs. Supports recruiting efforts (interviews, hiring).
Collaborates internally with Country TA Directors, Clinical Research Director (CRD), CRA managers, Monitoring Excellence, Vendor management, Vendor Strategy and Management to develop and build the territory of principal investigators and sites
Collaborates externally with Investigators, Functional Resourcing Vendors, regulators and Pharma Industry.
Oversight and management of local vendors and partners to ensure consistency across country monitoring organization. Will work closely with Product lifecycle management (PLMs) and CRA managers to ensure consistency across all monitoring resources. Also, accountable for quality and compliance in monitoring function and the development and execution of Strategic Quality Initiatives within the monitoring function.
In conjunction with Monitoring Excellence develops monitoring resourcing strategies in the country/cluster with vendors and CRDs to meet current and future resource demands
Works with vendors, positions and places CRAs for greatest efficacy & effectiveness
Accountable for the overall oversight of all Functional Service Providers (FSP) CRAs
Collaborates and works closely with the other GCTO management roles, the GCTO Headquarter teams, quality compliance, finance, Information Technology (IT) and Human Resources (HR).
A member of the local Leadership Team for GCTO
Works closely with the Country/cluster Leadership team, sponsor and supports strategic initiatives across Global Clinical Development and Global Clinical Trial Operations.
This position and direct reports have a significant impact on the ability to effectively conduct clinical studies and develop the pipeline, while maintaining regulatory requirements and compliance.
The position will directly impact the country’s ability to reach business targets and objectives and build productive collaboration with internal and external business partners.
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.
Who we are …
Merck & Co., Inc., Kenilworth, New Jersey, USA is known as “Merck” in the United States, Canada & Puerto Rico. We are known as “MSD” in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.
We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world’s biggest investors in Research & Development.
Education Minimum Requirements
Bachelor of Science degree or equivalent healthcare experience
Medical Doctor (MD), Doctorate (PhD), Pharmaceutical Doctorate (Pharm D), Master of Science (MS) preferred
Required Experience and Skills
Minimum of 12 years´ experience within Pharmaceutical Industry
Minimum of 10 years´ experience in clinical trial organization
Minimum of 5 years´ experience in a functional management position
Preferred Experience and Skills
Management of CRAs and familiarity with outsourcing and flexible resourcing models
What we look for …
In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.
To make a difference in the lives of people globally through our innovative medicines, vaccines, and animal health products. We are committed to being the premier, research-intensive biopharmaceutical company and are dedicated to providing leading innovations and solutions for today and the future.