Job Description

This role will be key to further develop the country capabilities in clinical research. Under the directionof the country or cluster CRD/TA-Head the person will be responsible for the end-to-end performance of clinical trials in 1 or several Therapeutic Areas (TA), from feasibility to close out in 1 or several countries. The role will be responsible for oversight of the employees working in the TA, with line management of CRMs and functional oversights of other roles in their studies. At the discretion of the CRD/TA Head, the role could also be responsible for direct project work and will ensure excellent study performance with strict adherence to local regulations, our company's SOPs and ICH GCP.

Asline manager the role is critical to develop key talents in the organization to ensure a pool of successors in critical roles.

Therole will work at country level with other local stakeholder like GMA, GHH, PV and regulatory to ensure alignment and development of the country capabilities and collaborates and works closely with other stakeholders in the TA in GCTO & GCD.

Responsibilitiesinclude, but are not limited to:

• Willlead 1 or several TA of the growing portfolio in the country.

• Accountablefor the successful execution, enrollment and quality of their clinical trial portfolio.

• Accountableto ensure performance metrics, timelines and key milestones are met in compliance with ICH/GCP and country regulations, our company's policies and procedures,quality standards and adverse event reporting requirements internally and externally.

• Accountableto develop operational strategies and quality plans for the conduct of all programs and studies in the TA portfolio.

• Collaborateswith other TA directors, local and regional stakeholder in GCTO in order to develop and build territory of principal investigators and sites.

• Ensuresoversight and line management of Clinical Research Manager (CRM) team.

• Overseethe performance management and career development of staff and effectively manage performance issues.

• Leada team independently with supervision from CRD/TAH to high performance.

• Accountablefor CRM performance reviews, including addressing low performance situations, and taking appropriate actions.

• Ensureskey talent development and retention.

• Collaboratesinternally with the cross-functional teams on local, regional and global level.

• Collaboratesexternally with investigators, regulators and vendors

• Supportsstrategic initiatives across country, Global Clinical Development GCD and GCTO.

• Supportslocal strategy development consistent with long-term corporate needs in conjunction with CRD.

• Togetherwith direct reports contributes significantly to effective conduct of clinical studies and to develop the pipeline, while maintaining regulatory requirements and compliance.

• MainPoint of Contact (POC) for assigned protocols and link between Country Operations and Clinical Trial Team (CTT).

• Responsiblefor 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.

• Reviews Monitoring Visits Reports and escalates performance issues and training needs toCRA-Manager and/or functional vendor and internal management as needed. Performs Quality control visits as required.

• Leadslocal study teams to high performance: trains in the protocol other local roles, closelycollaborates 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).

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

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

• Escalatesas needed different challenges and issues to TA-Head/CRD/CCQM and or CTT (as appropriate).

• Identifiesand shares best practices across clinical trials, countries, clusters.

• Mayact as a mentor.

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

• CountryPOC for programmatically outsourced trials for assigned protocols.

• Asa customer-facing role, this position will build business relationships and represent our company with investigators and medical centers.

• Serveslocal 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 corporateneeds in conjunction with CRD, TA-Head and Regional Operations.

Extent of Travel: Up to 30% of working time

Skills:

• Expertisein project and site management. The position requires demonstrated successful implementation of project management skills at program and site level.

• Strongorganizational skills with demonstrated success required.

• Requiresability to make decisions independently and oversee important activities relevant to clinical research activities according to predetermined global policies and commitments.

• Requiresa complete understanding of ICH GCP and global/regional/local regulatory environment.

• Strongscientific and clinical research knowledge is required. Including extensive knowledge of regional and/or country clinical trial landscape.

• Deepunderstanding of our research & development division organizational structure and cross-functional roles and responsibilities of its members.

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

• Experiencefunctioning as a key link between Country Operations and Clinical Trial Teams.

• Communicateseffectively and fosters a collaborative spirit in a remote/virtual environment and across countries, cultures and functions.

• Ability,experience, and skills to proactively manage resource allocation, processes (and controls), productivity, quality and project and/or program delivery.

• OverseeTA strategy alignment and consolidate relevant information, within specific indications, es