Director/Sr. Director, Clinical Operations

Apex Systems; Richmond (VA); Hybrid; USD 120,000 - 160,000; Full time

Job summary

A leading company is seeking a Director/Sr. Director of Clinical Operations to manage global phase 3 study start-ups in the rare disease sector. This role involves overseeing clinical trials, vendor management, and ensuring compliance with regulations. Ideal candidates will have extensive experience in clinical trial management and a strong background in drug development, particularly in liver diseases. The position offers a hybrid work model and a comprehensive benefits package.

Benefits

Medical Insurance

Dental Insurance

Vision Insurance

401K Program

Employee Stock Purchase Program

Health Savings Account

Employee Assistance Program

Qualifications

• 8+ years of clinical trial management experience.
• Experience managing non-US clinical trials.
• Expert in late-stage drug development.

Responsibilities

• Lead study start-up activities for global phase 3 trials.
• Manage external vendors for protocol compliance.
• Track timelines and resolve compliance issues.

Skills

Project Management

Communication

Adaptability

Education

BA/BS

Tools

SmartSheets

Job description

Director/Sr. Director, Clinical Operations

Director/Sr. Director, Clinical Operations 2073835

Location: Cambridge, MA (Hybrid)

Focus: Rare Disease

Job Overview: In this role, you will manage clinical operations and lead global phase 3 study start-ups, ensuring timely execution and resource optimization.

Primary Job Responsibilities:

• Lead study start-up activities for a global phase 3 trials
• Manage external vendors to ensure protocol compliance
• Handle study monitoring, data collection, and team support
• Provide operational input on clinical development strategies
• Track timelines, enrollment, and adherence to study plans
• Identify and resolve risks or compliance issues promptly

Primary Job Requirements:

• BA/BS with 8+ years of clinical trial management, including vendor and CRO oversight.
• Required experience managing non-US clinical trials.
• Expert in late-stage drug development and study start-up leadership.
• Preferred experience in liver disease treatments, especially NASH.
• Proficient in GCP, ICH guidelines, and CFR compliance.
• Skilled in project management, communication, and adaptability.
• Experience with tools like SmartSheets is a plus.

About Stratacuity:

Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.

Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us.

EEO Employer

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at [e-mail] or 844-463-6178 .

Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing in Talent Satisfaction in the United States and Great Place to Work in the United Kingdom and Mexico.

Apex Benefits Overview:Apex offers a range of supplemental benefits, including medical, dental, vision, life, disability, and other insurance plans that offer an optional layer of financial protection. We offer an ESPP (employee stock purchase program) and a 401K program which allows you to contribute typically within 30 days of starting, with a company match after 12 months of tenure. Apex also offers a HSA (Health Savings Account on the HDHP plan), a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program and other discounts. In terms of professional development, Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA. Apex has a dedicated customer service team for our Consultants that can address questions around benefits and other resources, as well as a certified Career Coach. You can access a full list of our benefits, programs, support teams and resources within our ‘Welcome Packet’ as well, which an Apex team member can provide.