This position is HYBRID in Bethesda, MD and will require you to go on site 2-4 days a week.

Roles and Responsibilities

• Serves as study lead and primary (internal and external) contact

• Leads and manages clinical research studies to ensure studies are conducted in accordance with approved scope of work/budget, US and Ex US regulatory guidelines and operate within established timelines

• Manages outsourced clinical study functions, which may include contracted investigational supply, data management, biostatistics, and central laboratory

• Generates and presents frequent study status updates and reports to sponsor

• Creates and reviews clinical study documents, including protocols, ICF templates, study budgets, site log/form templates, study manuals and plans, site binders, etc.

• Oversees and tracks patient recruitment and pro-actively identifies ways to prevent recruitment delays

• Drives and facilitates clinical teamwork and communications to ensure timely attainment of trial milestones

• Ensures accuracy of reports and material work product

• Presents at project meetings such as investigator meetings and new client meetings

• Updates management accurately and regularly through frequent communication

• Pro-actively Identifies issues and develops problem-solving strategies to ensure study timelines are met

• Manages subject accrual, retention, and compliance

• Ensuring that study Trial Master File is maintained and up to date and manages TMF audits as needed

• Writes and updates SOPs

• Prepares for and participates in third-party audits and regulatory inspections

• Complies with ICH GCP guidelines, FDA regulations, and company SOPs

• Manages and resolves conflicting priorities to deliver on commitments

• Performs additional duties as assigned.

Qualifications

• Minimum BS/BA from an undergraduate program or equivalent experience

• 5 years’ clinical operations/ management experience

• Proven ability to be careful, thorough, and detail-oriented

• Strong organizational skills and the ability to multi-task and work effectively in a fast-paced environment

• Strong analytical, negotiation, meeting management, cross-functional team, and leadership skills

• Excellent communication and interpersonal skills with customer service orientation

• Proficient with MS Office Suite, particularly Word and Excel

• Self-starter who thrives in a collaborative team environment

• Flexibility to travel up to 20% of time

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent

• Maintaining an inclusive environment through persistent self-reflection

• Building a culture of care, engagement, and recognition with clear outcomes

• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.