Clinical Trial Operations Lead/Clinical Trial Manager

Job Description

This position leads the operational planning and execution of one or more clinical trials or significant aspects thereof. In this position, you will have the opportunity to demonstrate your leadership and technical skills as part of a global, cross-functional team. You will apply project management, communication, and collaboration skills in support of our clinical trials. 

Job Responsibilities:

Responsible for the operational planning, feasibility, and execution of a clinical trial. This may include:

• May serve as the clinical trial team lead 
• May lead team in key study planning, development, and execution elements (e.g., data management deliverables, trial level plans/timelines, country/site selection, site materials, system updates, investigator meeting planning, communication plans, preparation of status update reports, study close out activities). 
• Leads team for timeline management, risk identification and mitigation, issue resolution. 
• May facilitate and collaborate with key internal/external stakeholders (e.g., study team, country teams, vendors, committees) in support of clinical study objectives. 
• Accountable for managing any study specific partners and/or vendors. 

Core Skills

Demonstrated ability to drive and manage operational activities on clinical protocols. This position may represent the company through external partnerships, collaborations, and key strategic engagements. This includes the ability to:

• Solid knowledge of clinical research regulatory requirements (e.g., Good Clinical Practice (GCP) and International Council for Harmonisation (ICH) 
• Ability to manage multiple competing priorities with good planning, time management and prioritization skills 
• Solid understanding of the principles of project planning & project management 
• Good analytical skills to drive operational milestones 
• Influence opinions and decisions of internal and external customers/vendors, across functional areas, and within the division 
• Interact with key stakeholders across department, division, and company. Role requires a proactive approach and leadership driving toward study goals. 
• Applying leadership skills to processes, leading meetings, and influencing peers in a matrix environment. 
• Problem solving, prioritization, conflict resolution, and critical thinking skills 
• Strong communication, writing, and presentation skills 
• Intermediate knowledge in Microsoft office or similar (Excel, PowerPoint, Word, Outlook, etc.)

Education/Experience

• A minimum of a Bachelor's Degree and 5+ years of pharmaceutical, clinical drug development, project management, and/or medical field experience -OR-
• A Master's Degree and 3+ years of pharmaceutical, clinical drug development, project management, and/or medical field experience -OR-
• A PhD/PharmD Degree
• Preferred: A Degree in life sciences

Ideal candidate would have:

• Experienced conducting global clinical trials, including trial initiation through database lock
• Experienced managing and driving operational activities on protocols for immunology related clinical trials
• Experience with imaging vendors, clinical outcome assessments, biomarker sample collection and management, central labs and external data monitoring committee for immunology clinical trials
• Highly Preferred: Experienced conducting clinical trials for Gastroenterology, Dermatology, Rheumatology, especially autoimmune or immune-mediated disorders

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Required Skills:

Preferred Skills:

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As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.  As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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The salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits.  Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

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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. 

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