Senior Scientist, Study Manager Full-time

Clinical Trial Operations Lead

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.

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.

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., GCP and 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.)

Bachelor's Degree +5 years of pharmaceutical, clinical drug development, project management, and/or medical field experience OR Master's Degree +3 year of pharmaceutical, clinical drug development, project management, and/or medical field experience OR PhD/PharmD Degree Degree in life sciences, preferred.

Ideal candidate would have:

• Experience in conducting global clinical trials, including trial initiation through database lock.
• Highly Preferred: experience in conducting clinical trials in ophthalmology, such as uveitis, AMD (age-related macular degeneration), thyroid eye disease.
• Experience in managing and driving operational activities on protocols for ophthalmology clinical trials.
• Experience with imaging vendors, clinical outcome assessments, biomarker sample collection and management, and external data monitoring committee for ophthalmology clinical trials.
• Experience in managing imaging vendors for ophthalmology clinical trials.
• Experience with ophthalmologic assessments, e.g (slit lamp. dilated indirect ophthalmoscopy {DIO}, imaging assessments such as optical coherence tomography {OCT}; fluorescein angiography {FA}, fundus photography {FP} and visual acuity assessments such as best corrected visual acuity {BCVA} performed and as well as supplies and equipment needed at sites in ophthalmology clinical trials.

Required Skills: Accountability, Adaptability, Clinical Data, Clinical Operations, Clinical Research, Clinical Study Design, Clinical Trial Compliance, Clinical Trial Management, Clinical Trials Operations, Data Analysis, Ethical Standards, ICH GCP Guidelines, Ophthalmology, Regulatory Compliance, Regulatory Documents

Accountability, Adaptability, Clinical Data, Clinical Operations, Clinical Research, Clinical Study Design, Clinical Trial Compliance, Clinical Trial Management, Clinical Trials Operations, Data Analysis, Ethical Standards, ICH GCP Guidelines, Ophthalmology, Regulatory Compliance, Regulatory Documents

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Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday – Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

The salary range for this role is $117,000.00 – $184,200.00. 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.

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

Regular

No relocation

No

10%

Not Applicable

1st – Day

Yes

N/A

04/1/2026

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