Clinical Research Manager, Immunology, Remote

MSD • Rahway, NJ

2d • Remote

About The Position

This role is primarily accountable for the end-to-end performance and project management for assigned protocols in a country in compliance with International Council for Harmonisation Good Clinical Practice (ICH-GCP) and country regulations, our Company policies and procedures, quality standards and adverse event reporting requirements internally and externally. The CRM could be responsible for a particular study for several countries in a cluster. Responsibilities include, but are not limited to: Main Point of Contact (POC) for assigned protocols and link between Country Operations and clinical trial team (CTT). Responsible for project management of the assigned studies: pro-actively plans, drives and tracks execution and performance of deliverables/timelines/results to meet country commitments from feasibility and site selection, recruitment, execution and close out. Accountable for performance for assigned protocols in a country in compliance with ICH/GCP and country regulations, our Company policies and procedures, quality standards and adverse event reporting requirements internally and externally. Reviews Monitoring Visits Reports and escalates performance issues and training needs to Clinical Research Associate (CRA) Manager and/or functional vendor and internal management as needed. Performs Quality control visits as required. Leads local study teams to high performance: trains in the protocol other local roles, closely collaborates with and supports Clinical Research Associates (CRAs) as protocol expert and coordinates activities across the different local country roles ensuring a strong collaboration (including the Clinical Trial Coordinator (CTC), CRAs and Clinical Operations Manager (COM)). Responsible for creating and executing a local risk management plan for assigned studies. Ensures compliance with Clinical Trial Management System (CTMS), Electronic Trial Master File (eTMF) and other key systems in assigned studies. Escalates as needed different challenges and issues to Therapeutic Area (TA) Head/Clinical Research Director (CRD)/Country Clinical Quality Manager (CCQM) and or CTT (as appropriate). Identifies and shares best practices across clinical trials, countries, clusters. Responsible for collaboration with functional outsourcing vendors, investigators, other external partners in assigned studies. Country POC for programmatically outsourced trials for assigned protocols. As a customer-facing role, this position will build business relationships and represent our Company with investigators. Serves local business needs as applicable in his/her country (if delegated can sign contracts and manage budgets). Supports local and regional strategy development consistent with long‐term corporate needs in conjunction with CRD, Therapeutic Area Head (TAH) and Regional Operations. Collaborates internally with Headquarters (HQ) functions, regional and local operations, European Union (EU) Clinical Development, Pharmacovigilance, Global Medical Affairs to align on key issues/decisions across the trials. Consult with Global Human Health (GHH) as needed.

Requirements

• 5+ years of experience in clinical research
• Bachelor's degree in science (or comparable)
• Knowledge in Project Management and site management.
• Strong organizational skills with demonstrated success required.
• Requires ability to make decisions independently and oversee important activities relevant to clinical research activities according to predetermined global policies and commitments with the support, oversight and supervision of the TA Head or CRD.
• Requires strong understanding of local regulatory environment.
• Strong scientific and clinical research knowledge is required.
• Strong understanding of clinical trial planning, management and metrics is essential as well as the ability to focus on multiple deliverables and protocols simultaneously.
• Experience functioning as a key link between Country Operations and Clinical Trial Teams.
• Communicates effectively and builds a collaboration spirit in a remote/virtual environment and across countries, cultures and functions.
• Ability and skills to manage resource allocation, processes (and controls), productivity, quality and project delivery.
• Proficiency in written and spoken English and local language.
• The incumbent must be competent and effective in written and verbal communication.
• Strategic thinking.
• Ability to work efficiently in a remote and virtual environment.
• Understand cultural inclusion.
• The position requires proven strong project management skills and/or project management certification or relevant training program/close mentoring.
• Strong leadership skills that enable and drive alignment with the goals, purpose and mission of our Company's Research Labs (CRL), Global Clinical Development (GCD) and Global Clinical Trial Operations (GCTO).
• Ability to identify problems, conflicts and opportunities early and lead, analyze and prepare mitigation plans and drive conflict resolution is critical.
• Required to negotiate skillfully in tough situations with both internal and external groups; settle differences with minimum disruption.
• Educational/pedagogic, diplomatic and empathic skills to effectively build and maintain professional relationships with investigators and other stakeholders.

Nice To Haves

• Clinical Research Associate (CRA) experience preferred
• Immunology experience preferred
• Trial management experience preferred
• Advanced degree (e.g., Master degree, MD, PhD)

Responsibilities

• Main Point of Contact (POC) for assigned protocols and link between Country Operations and clinical trial team (CTT).
• Responsible for project management of the assigned studies: pro-actively plans, drives and tracks execution and performance of deliverables/timelines/results to meet country commitments from feasibility and site selection, recruitment, execution and close out.
• Accountable for performance for assigned protocols in a country in compliance with ICH/GCP and country regulations, our Company policies and procedures, quality standards and adverse event reporting requirements internally and externally.
• Reviews Monitoring Visits Reports and escalates performance issues and training needs to Clinical Research Associate (CRA) Manager and/or functional vendor and internal management as needed.
• Performs Quality control visits as required.
• Leads local study teams to high performance: trains in the protocol other local roles, closely collaborates with and supports Clinical Research Associates (CRAs) as protocol expert and coordinates activities across the different local country roles ensuring a strong collaboration (including the Clinical Trial Coordinator (CTC), CRAs and Clinical Operations Manager (COM)).
• Responsible for creating and executing a local risk management plan for assigned studies.
• Ensures compliance with Clinical Trial Management System (CTMS), Electronic Trial Master File (eTMF) and other key systems in assigned studies.
• Escalates as needed different challenges and issues to Therapeutic Area (TA) Head/Clinical Research Director (CRD)/Country Clinical Quality Manager (CCQM) and or CTT (as appropriate).
• Identifies and shares best practices across clinical trials, countries, clusters.
• Responsible for collaboration with functional outsourcing vendors, investigators, other external partners in assigned studies.
• Country POC for programmatically outsourced trials for assigned protocols.
• As a customer-facing role, this position will build business relationships and represent our Company with investigators.
• Serves local business needs as applicable in his/her country (if delegated can sign contracts and manage budgets).
• Supports local and regional strategy development consistent with long‐term corporate needs in conjunction with CRD, Therapeutic Area Head (TAH) and Regional Operations.
• Collaborates internally with Headquarters (HQ) functions, regional and local operations, European Union (EU) Clinical Development, Pharmacovigilance, Global Medical Affairs to align on key issues/decisions across the trials.
• Consult with Global Human Health (GHH) as needed.

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays, vacation, and compassionate and sick days
• annual bonus
• long-term incentive

What This Job Offers

• Job Type: Full-time
• Career Level: Senior