Clinical Research Manager

Job Title: Clinical Research Manager (CRM)

Position Purpose:

The Clinical Research Manager (CRM) is responsible for the following:

• Primarily accountable for end-to-end performance and project management for assigned protocols in a country in compliance with International Committee on Harmonization (ICH) / Good Clinical Practice (GCP) and country regulations, Client policies and procedures, quality standards and adverse event reporting requirements internally and externally.
• For certain studies, could be responsible for several countries in a cluster.

Organizational Relationships:

• Reports to ExecuPharm-assigned Line Management with day-to-day direction from Client. Refer to Organizational Chart for details regarding assigned role and associated reporting structure.
• Collaborates internally with (Headquarters) HQ functions, regional and local operations, European Union (EU) Clinical development, Pharmacovigilance, Global Medical Affairs (GMA) to align on key issues/decisions across the trials. Global Human Health (GHH) to be consulted as needed.

Primary Responsibilities:

• Main Point of Contact (POC) for assigned protocols and link between Country Operations (CO) and clinical trial team (CTT).
• Responsible for project management of the assigned studies:

• Proactively plans/drives/tracks execution and performance of deliverables/timelines/results to meet country commitments from feasibility and site selection, recruitment, execution and closeout.
• Accountable for performance for assigned protocols in country in compliance with International Committee on Harmonization (ICH) /Good Clinical Practice (GCP) and country regulations, Client policies and procedures, quality standards and adverse event reporting requirements internally and externally
• Performs quality control visits as required.
• Reviews Monitoring Visits Reports (MVRs) and escalates performance issues and training needs to CRA manager and /or functional vendor and internal management as needed.

• Leads local study teams to high performance:

• Trains in the protocol for other local roles.
• Collaborates with and supports Clinical Research Associates (CRAs) as protocol expert.
• 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) Director / Clinical Research Director (CRD) / Clinical Quality Management (CQM) and or Clinical Trial team (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 Client 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 Clinical Research Director (CRD), Therapeutic Area Head (TAH) and Regional Operations.
• Lead and contribute to initiatives and projects adding value to the business and supporting the strategy.
• Completes training assigned by Client and/or PXL, as necessary, including general training requirements, SOPs, and system and process related training.
• Adheres to PXL and Client SOPs and processes.

Education and Certification:

• Bachelor’s degree in science (or comparable) required; advanced degree (Master’s degree, MD, PhD) preferred.

Skills and Experience:

• 5-6 years of experience in clinical research; CRA experience preferred.
• Knowledge in Project Management/Site Management with proven strong project management skills and /or project management certification or relevant training program/close mentoring.
• Strong organizational skills with demonstrated success required.
• Requires ability to make decisions independently while overseeing important activities relevant to clinical research in the country according to predetermined global policies and commitments with the support, oversight, and supervision of the Therapeutic Area (TA) or Country Research Director (CRD).
• Requires strong understanding of the local regulatory environment.
• Strong scientific and clinical research knowledge is required with strong understanding of clinical trial planning, management, and metrics 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.
• Strategic thinking.
• Ability to work efficiently in a remote and virtual environment.
• Strong leadership skills that enable and drive alignment with the goals, purpose and mission of Client, 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. Examples of common problems include low patient recruitment; inadequate staff to meet business needs; performance or compliance issues; working with regulatory issues and the broader organization; and resolution of conflictive situations