Clinical Research Director

Job Description

The Clinical Research Director (CRD) is the Clinical Operations lead in a country/cluster and is responsible

for execution of all Clinical Trials in scope for GCTO country operations.

Adherence to GCP, local and global policies and procedures to conduct high-quality, inspection ready

studies is essential. The position is accountable for trial quality and audit responses and completion of

CAPAs. The incumbent ensures a single point of contact for managing clinical trial execution in all its

aspects across phases in scope of GCTO within the country/cluster.

The position has multiple touch points across the company which will be dependent on country/cluster

and the study type and stage.

CRD is the primary country/ cluster level contact for GCTO and has the following key responsibilities:

- Supports the regional GCTO leadership team, leading strategic development of their country /

cluster to deliver clinical trials as per global clinical research pipeline requirement

- Strategic country / cluster representative for initiatives at all levels of the organization

- Build and lead the team to effectively manage resources ensuring appropriately skilled and high

performing team to effectively deliver the portfolio across therapy areas and achieve on agreed

GCTO, GCD, and company objectives

- Leads strategic development and management of institutional & investigator relationships in

conjunction with GTCO / GCD Therapy Areas, and when appropriate Human Health

- Working with regional and global colleagues develops and executes the GCTO strategy for the

country/cluster - such as Industry associations

Leadership and Management of the GCTO country / cluster Organization:

- Recruits and hires talent

- Proactively manages and develops talent

- Proactively identifies new opportunities and gaps to support emerging needs and addresses by

reallocating and training of existing staff and/or external recruitment

- Creates an empowering, compliant, collaborative, and innovation-focused work environment

- Builds a culture of quality and compliance through training, oversight, and collaboration

- Oversight to ensure appropriate scientific and operational training for staff members.

Clinical Operation Management:

Ensures a single point of contact for managing clinical trial execution in all its aspects across all studies &

phases in scope of GCTO within the country/cluster.

Leadership and oversight of the following:

- Research Labs / GCD / GCTO goals, initiatives and expectations

- Development and delivery of company standards in given geography

- Activities of all cluster/country level GCTO team & all programs and studies

- Approved administrative budget to support GCTO team (e.g., salaries & travel)

- Country level operational study budgets

- Regulatory Inspections and internal audits; responding to inquiries by health authorities, ethics

committees, and internal auditors in conjunction with CCQM, compliance, Regulatory,

Pharmacovigilance (PV) and Medical Affairs

- Responsible and supports development of audit responses and completion of CAPAs

Collaborates and supports:

• Functional Service Provider (FSP) Senior, Regional and local Leadership to ensure adequate and

appropriate resourcing for company internal clinical trial portfolio

• Clinical Research Organization (CRO) Senior, Regional and local Leadership to ensure the

successful conduct of outsourced clinical trials

Engagement With Key External Stakeholders

- Supporting Management and the clinical operations of studies managed by GCTO

- Support the development and management of Investigator and operational relationship and Therapy Areas, and when appropriate Human Health colleagues

- Contribute to the program life-cycle management through effective study allocation and

execution (prioritizing programs, working with Key Opinion Leaders (KOLs), etc.).

Quality / Compliance Adherence / Standard:

- Ensure that compliance, quality and timeline objectives are met for all trials executed in the

country.

- Sets clear performance standards and holds self and organization accountable for achieving

results. Embraces GCTO metrics and performance standards (KPI’s)

- Work collaboratively in a matrix organization with all groups within GCTO, especially with Clinical

Sciences and Study Management (CSSM), Clinical Quality Managers (CQMs) and Regional

Operations Teams, to deliver objectives

- Take responsibility for any clinical audits, working closely with the Quality Assurance (QA) group

and the Good Clinical Practice Quality and Compliance Council (GCP QCC).

Division/Area - Clinical Operations

Reports to GCTO Regional Research Director (RRD) or Cluster Clinical Research Director

Extent of Travel up to 30%

Qualifications, Skills

CORE Competency Expectations:

& Experience

• Significant Management experience in a Clinical Trials setting with the ability to service and

collaborate with different stakeholders within GCTO

• Management expertise should cover management of budget, travel, resources, headcount,

processes (and controls), productivity, quality and project delivery

• A complete understanding of ICH GCP and Global/Regional/Local regulatory requirements is

required.

• Strong Communication skills requiring proficiency in written and spoken English and preferably

local language. The incumbent must be competent and effective in written and verbal

communication.

• Strategic thinking

Behavioural Competency Expectations:

• High emotional intelligence

• Strong leadership that will attract, motivate, inspire, develop and retain talented staff. In addition,

Leadership skills that enable and drive alignment with the goals, purpose and mission of the company

Research Labs, Global Clinical Development (GCD) and GCTO

• Positive proven success in people management

Educational Requirements:

Required:

• Bachelor’s degree in science or equivalent healthcare experience

Preferred:

Advanced degree, (e.g., MD, PhD, Pharm D, MS, MBA)

Required Skills:

Adaptability, Budget Management, Clinical Quality Management, Clinical Research, Clinical Risk Management, Clinical Trial Documentation, Clinical Trial Management, Clinical Trial Planning, Clinical Trials, Clinical Trials Operations, Community Leadership, Decision Making, Emotional Intelligence, Ethical Standards, Good Clinical Practice (GCP), ICH GCP Guidelines, Multiple Therapeutic Areas, People Leadership, Pharmacovigilance, Process Improvements, Professional Networking, Regulatory Requirements, Resource Allocation, Strategic Thinking

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

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:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

06/28/2026

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.