Job Description

Join a Global Innovative Pharmaceutical Company

Supportive and flexible team culture

Great opportunity for Personal and Professional development

Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.

THE OPPORTUNITY:

This role will be key to further developing the country\'s clinical research capabilities. 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, Company SOPs, and ICH GCP.

The role is responsible for oversight of all the employees working in the TA, with line management for CRMs and functional supervision of other roles in his studies.

As line manager, the role is critical to develop key talents in the organization to ensure a pool of successors in crucial roles.

The role will work at the country level with other local stakeholders like GMA, GHH, PV, and regulatory to ensure alignment and development of the country\'s capabilities to represent the CRD of the cluster in local management.

What will you do:

Will lead 1 or several TA of the growing portfolio in the country

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

Responsible for timelines and that key milestones are met.

Accountable for performance metrics and developing operational strategies and quality plans for the conduct of all programs and studies in the TA portfolio

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

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

Leads team independently with supervision from CRD to high performance

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 the effective conduct of clinical studies and to develop the pipeline while maintaining regulatory requirements and compliance

This position directly impacts the country\'s ability to reach business targets and objectives and ensures that productive collaboration with internal and external business partners is built.

This role will involve up to 30% traveling

What should you have

Minimum of 10 years\xe2\x80\x99 experience in a clinical trial organization with at least 2 years\' experience in a functional management position or Experienced Senior Clinical Research Manager preferred.

CRA, project management, and Line management experience

Educational Requirements:

Bachelor\'s degree in Science or equivalent healthcare experience Preferred:

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

Business and financial acumen with strategic thinking

Ability to think cross-functionally and work across boundaries internationally

Should identify problems, conflicts, opportunities early and lead, analyze mitigation plans to drive conflict resolution

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.

Behavioural Competency Expectations:

High emotional intelligence, Strong leadership and negotiation skills

Positive proven success in people management with demonstrated ability to build relationships with senior business executives

Excellent interpersonal and communication skills with ability to manage conflict

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

Who we are:

We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world\'s most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for \xe2\x80\xa6

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us\xe2\x80\x94and start making your impact today.

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):

Merck Sharp & Dohme