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, 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, 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-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 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 the 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 business as needed.

Qualifications, Skills& Experience

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 with the support, oversight and supervision of the TA-Head or CRD.

• Requires understanding of local regulatory environment.

• Scientific and clinical research knowledge is required.

• Understanding of clinical trial planning, management and metrics is essential as well as the ability to focus on multiple deliverables and protocols simultaneously.

• Ability to function 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 to manage 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.

• Aptitude for building leadership skills that enable and drive alignment with the goals, purpose and mission of our R&D Department, Global Clinical Development (GCD) and the Clinical Operations Team.

• Ability to identify problems, conflicts and opportunities early, analyses 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:

1) Low patient recruitment.

2) Inadequate staff to meet business needs.

3) Performance or compliance issues.

4) Resolution of conflictive situations.

• Understand cultural diversity.

• Strong diplomatic and empathic skills to effectively build and maintain professional relationships with investigators and other stakeholders.

Qualification & Experience:

• 4+ years of experience in clinical research.

• Bachelor's Degree in Science (or comparable).

• CRA working experience preferred.

Required Skills:

Preferred Skills:

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