Clinical Trial Coordinator Manager

Job Description

This role is accountable for execution and oversight of local operational clinical trial activities in compliance with ICH/GCP and country regulations, our company's policies and procedures and with quality standards internally and externally.

Under the oversight of the CRD / Director, Clinical Research, the individual is responsible to manage/oversee a team of CTCs.

As line manager the role is critical to continuously develop future talent by providing training, support and mentoring to the CTCs, as well as for interns delegated to the Clinical Operations team based on the Internship program, while properly managing situations of low or non-performance.

The role will work across the different country operations roles (e.g. CRM, CRA-Manager, Partners, TA-Head, CRD and Sr.COM) to ensure alignment and development of the country CTC capabilities. The person contributes to CTC capacity/resource planning activities to ensure efficient allocation of resources and work.

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.

Responsibilities include, but are not limited to:

• Has significant impact on how a country can deliver country-specific trial commitments and objectives especially during study start-up

• Ensure and oversee proper on‐boarding and off‐boarding of employees, compliance to initial and ongoing trainings.

• Train and oversee the CORE competencies, ICH‐GCP knowledge, Clinical Research environment etc.

• Assure adherence to GCP guidelines, processes and procedures related to direct reports’ activities and performance.

• Ensure direct reports are compliant to the timelines and key business metrics.

• Review and approve timesheets, Global Time Tracking compliance, expense reports, time‐off requests and provide proper oversight of CTC's productivity/utilization.

• Provide input for capacity planning, including reporting of current manpower and forecasting of CTC capacity and needs, to provide efficient use of resources.

• Work with CRDs, TA-Heads, CRMs, CRA-Manager, Sr. COM, CRAs, Partners and other functions to ensure consistency of processes and protocol implementation across the country, to reduce variability and provide predictability.

• Interacts with CRMs and sites as needed to resolve operational issues, to meet commitments in a timely manner and in coordination with the study CRM and CRA.

• Interface with GCTO partners on clinical trial execution as assigned; including acts as lead liaison with CTC FSP partners in facilitating coordinated process and country delivery.

• Escalates site performance issues to CRM and CRD/TA-Head.

People and Resource Management:

• Manages CTC – career development, performance reviews, etc., including addressing low performance situations, and taking appropriate actions.

• Supports and resolves escalation of issues from CTCs.

• Manages capacity/resource planning activities to ensure efficient allocation of resources and work. Manage local conflicts between resource and work.

• Ensures CTC compliance to corporate policies, procedures and quality standards

Skills:

• Demonstrates proactive leadership and must be able to in/directly influence vendors, external partners and country managers to deliver these commitments within specified timelines with minimal oversight from the line manager.

• Ability to proactively develop risk management and mitigation plans in the country and resolve issues locally. He/she is an independent decision maker with a clear understanding of the pros and cons of each decision and

• takes ownership of decisions.

• Ability to work independently and in a team environment

• Excellent people management, time management, project management and organizational skills

• History of strong performance and leadership

• Skills and judgment required to be a good steward/decision maker for the company

• Fluent in Local Language and business proficient in English (verbal and written)

• Excellent working knowledge of all applicable ICH/GCP regulations and Good

Documentation Practices and ability to work within these guidelines

• Expertise in and excellent working knowledge of core trial management systems and tools

• Strong coordination and organizational skills.

• High emotional intelligence

• Strong leadership skills with proven success in people management

• Excellent interpersonal and communication skills, conflict management

• Demonstrated ability to build relationships and to communicate effectively with internal stakeholders and external partners

• Fluency in both English and local language

Qualification & Experience:

• Minimum of 5 years experience within Clinical Research, preferred experience in the role of CTC, CRA or similar role

• Line management-recent experience preferred or at the minimum team leader experience

Educational Requirements: Required:

• Bachelor's Degree (or comparable) in Business Administration/ Life Science Preferred:

• Advanced degree, (e.g. BA/BS or higher) with a strong emphasis in science and/or Clinical Research Management/Administration.

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

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 …

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—and start making your impact today.

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

Residents of Colorado

Click here to request this role’s pay range.

New hires in office-based roles in the US & Puerto Rico will be required, subject to applicable law, to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption to this vaccination requirement that can be accommodated without an undue burden to the operation. However, subject to applicable law, employees working in roles that the Company determines require routine collaboration with external stakeholders, such as employees in health services, customer facing commercial, or research based roles, will be required to be fully vaccinated as a condition of employment.

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster

EEOC GINA Supplement​

OFCCP EEO Supplement

Pay Transparency Nondiscrimination

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Residents of Colorado:

Click here to request this role’s pay range.

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

Requisition ID:R203353