Job Description

This role will be key to further develop the country capabilities in clinical research. Under the oversight of the country or cluster CRD the person will be responsible for the end to end performance of clinical trials in 1 or several TA, from feasibility to close out in 1 or several countries. The role should be responsible for 30 to 50 clinical trials and will ensure excellent study performance with strict adherence to local regulations, our Company's SOPs and ICH GCP.
The role is responsible for oversight of all the employees working in the TA, with line management for Clinical Research Managers (CRM) and functional oversight of other roles in studies.
As line manager the role is critical to develop key talents in the organization to ensure a pool of successors in critical roles.
The role will work at country level with other local stakeholder like Medical, PV, regulatory and commercial to ensure alignment and development of the country capabilities and can represent the CRD of cluster in local management if required. CRD can delegate certain key tasks as needed.

Responsibilities include, but are not limited to:

Will lead 1 or several therapeutic areas of the growing portfolio in South Africa and Africa

Accountable for the successful execution, enrollment and quality of their clinical trial portfolio

Accountable to ensure timelines and key milestones are met

Accountable for performance metrics

Accountable to develop operational strategies and quality plans for the conduct of all programs and studies in the TA portfolio

Collaborates with other TA directors, local and regional stakeholder in GCTO in order to develop and build territory of principal investigators and sites

Ensures oversight and line management of Clinical Research Manager (CRM) team within TA

Leads team independently with supervision from CRD to high performance

Accountable for CRM performance reviews, including addressing low performance situations, and taking appropriate actions.

Ensures key talent development and retention

Collaborates and works closely with other stakeholders in the TA in GCTO & GCD regional and headquarter teams, quality, finance, IT and HR

Collaborates externally with investigators, regulators and vendors

Member of the GCTO country leadership team

Supports strategic initiatives across Global Clinical Development GCD and GCTO

Supports local strategy development consistent with long-term corporate needs in conjunction with CRD.

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

This position impacts directly the countryxc2xb4s ability to reach business targets and objectives and ensures that productive collaboration with internal and external business partners are built.

Qualifications, Skills & Experience:

Bachelorxe2x80x99s degree in science or equivalent healthcare experience

Preferred: Advanced degree, (e.g., MSc, Ph.D, MBA)

Minimum of 10 yearsxc2xb4 experience in clinical trial organization

Minimum of 2 yearsxc2xb4 experience in a functional management position

CRA , project management and CRM experience

Line management experience

Business and financial acumen

Strategic thinking

Ability to think cross-functionally and working across boundaries internationally

Ability to identify problems, conflicts and opportunities early and lead, analyse mitigation plans and drive conflict resolution is critical

Fluent in Local Language and business proficient in English (verbal and written) and excellent communication skills

Sound ICH-GCP knowledge and knowledge of Good Documentation Practices

Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.

High emotional intelligence

Strong leadership and negotiation skills

Positive proven success in people management

Demonstrated ability to build relationships with senior business executives

Influencing skills

Excellent interpersonal and communication skills, conflict management

Relationship management and networking: strong integration into local and HQ TA network and ability to build productive relationships with all parties

Effective time management

Effective communication with external customers (e.g. sites and investigators)

Reports to
Clinical Research Director (CRD)
Location: office-based
Extent of Travel:up to 30%

Current Employees apply

Current Contingent Workers apply

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status: Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

MSD