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Associate Clinical Research Manager (aCRM) - Infectious Disease (REMOTE)

USA - New Jersey - Rahway

Job Description

With support of other CRMs and/or TA-Head/CRD, this role is 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 policies and procedures, quality standards and adverse event reporting requirements internally and externally.
The aCRM could be responsible for a particular study for a country or 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.

  • o Reviews Monitoring Visits Reports and escalates performance issues and training needs to CRA-Manager and/or functional vendor and internal management as needed.

  • o 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 CTCs, CRAs and COMs).

  • 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.

  • Responsible for collaboration with functional outsourcing vendors, investigators, other external partners in assigned studies.

  • As a customer-facing role, this position will build business relationships and represent our Company with investigators.

  • Supports local and regional strategy development consistent with long‐term corporate needs in conjunction with CRD, TA-Head and Regional Operations.

  • Collaborates internally with HQ functions, regional and local operations, EU Clinical Development, Pharmacovigilance, Regulatory Affairs, Global Medical and Scientific Affairs to align on key issues/decisions across the trials. Consult with Human Health as needed.

Extent of Travel: Up to 30% of working time

Skills:

  • Knowledge in Project Management and/or site management.

  • Strong organizational skills with demonstrated success in related role or discipline required.

  • Requires ability to make decisions independently and oversee important activities relevant to clinical research activities according to predetermined global policies and commitments …

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