Clinical Research Manager - General Medicine (REMOTE)

Job Description

This role is primarily accountable for the end-to-end performance and project management for assigned protocols in a country in compliance with ICH/GCP and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally and externally.

The CRM (Clinical Research Manager) 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, 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 CRA (Clinical Research Associate) 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 CRAs as protocol expert and coordinates activities across the different local country roles ensuring a strong collaboration (including the CTC Clinical Trial Coordinator, CRAs and COM Clinical Operations Manager). 

• Responsible for creating and executing a local risk management plan for assigned studies.

• Ensures compliance with CTMS Clinical Trial Management System , eTMF electronic Trial Master File and other key systems in assigned studies.

• Escalates as needed different challenges and issues to TA Head/CRD Clinical Research Director/CCQM Country Clinical Quality Manager and or CTT Clinical Trial Team (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, TAH therapeutic head and Regional Operations.

• Collaborates internally with HQ functions, regional and local operations, EU Clinical Development, Pharmacovigilence, Global Medical Affairs to align on key issues/decisions across the trials. Consult with Human Health Division …