Clinical Research Manager (CRM) – Immunology (REMOTE)

Job Description

Position Description:

Clinical Research Manager (CRM) – Immunology (REMOTE)

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, Our Company's 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's 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 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, CRAs and COM).

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

• Ensures compliance with CTMS, eTMF and other key systems in assigned studies.

• Escalates as needed different challenges and issues to TA Head/CRD/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, TAH 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 GHH as needed.

Extent of Travel: Up to 30% of working time

CORE Competency Expectations:

• Knowledge in Project Management and site management.

• Strong organizational skills …