Actalent Bethesda , MD 20813
Posted 2 weeks ago
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 for other accommodation options.
Actalent