Senior Scientist, Study Manager - Atherosclerosis and Metabolism Clinical Operations

Merck & Co.; Rahway (NJ); On-site; USD 117,000 - 184,000; Full time

Job summary

Merck & Co. in Rahway, NJ is seeking a senior clinical operations leader to oversee the planning and execution of one or more clinical trials.

You will lead cross-functional teams, apply project management skills, and ensure adherence to GCP/ICH standards in a global context. You will coordinate trial milestones, manage timelines, risks, and communications with vendors and study teams, driving study goals while supporting collaboration across departments.

Qualifications

• Bachelor's degree in life sciences or related field with 5+ years of pharmaceutical/clinical drug development experience.
• Master's or PhD/PharmD is acceptable with relevant clinical development experience.
• Strong knowledge of GCP/ICH regulatory requirements and project management.

Responsibilities

• Plan, feasibility and execution of a clinical trial or major aspects thereof.
• May lead the clinical trial team and key study planning elements.
• Drive timelines, risk management, issue resolution and study milestones.
• Coordinate with internal/external stakeholders to support trial objectives.
• Manage study partners and vendors and ensure regulatory alignment.
• Lead meetings, decisions, and communications in a matrix environment.

Skills

Project management

Leadership

GCP/ICH knowledge

Time management

Communication

MS Office

Education

Bachelor's degree in Life Sciences

Master's degree in a relevant field

PhD/PharmD

Job description

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.
• 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/site teams, vendors, committees) in support of clinical study objectives.
• Accountable for managing any study specific partners and/or vendors.

Core Skills:

• 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:

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

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.

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:

EEOC Know Your Rights

EEOC GINA Supplement

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.

The primary location for this posting is: USA - New Jersey - Rahway

Where required by law, the compensation range for this role is provided below.

The salary range for the primary location of this role is:

$117,000.00 - $184,200.00

This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of 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 .

Additional location(s):

Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location.

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

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

N/A