6 month contact with a Large CRO
Job Description
We are seeking a dedicated Regulatory & Site Start Up Manager to direct and manage the global delivery of all required site activation, maintenance, and regulatory activities for selected studies or multi-protocol programs. The role includes overseeing pre-award activities, and managing the scope of work, budget, and resources.
ResponsibilitiesOversee the execution of site activation and maintenance for assigned projects, adhering to project timelines.Develop, implement, and maintain the Management Plan according to the Scope of Work and Project Plan.Ensure collaboration across Regulatory & Site Activation teams to deliver the agreed project scope in compliance with the RSU Management Plan.Create and review technical and administrative documentation to support business development and enable study initiation and maintenance.Provide specialist regulatory and technical scientific support for clinical trials to ensure compliance with regulatory requirements.Guide and oversee multi-regional and multi-protocol programs during start-up and maintenance phases.Determine regulatory strategy and parameters for submissions and necessary authorizations.Identify regulatory complexities and challenges, offering creative and practical solutions.Assess and review the regulatory landscape to support assigned studies.Execute operational strategy for the maintenance of clinical study approvals and negotiation of contracts.Work with Quality Management to ensure quality standards during site activation.Mentor and coach colleagues, ensuring accurate completion and maintenance of internal systems.Develop long-standing relationships with preferred clients.Deliver presentations and training to clients, colleagues, and professional bodies.Essential SkillsBachelor's Degree in Life Sciences or related field.7 years of relevant experience in a scientific or clinical environment, including international roles.Strong negotiation and communication skills.Excellent interpersonal skills and team player capabilities.Thorough understanding of regulated clinical trial environments and drug development processes.Proficiency in using systems and technology to achieve work objectives.Good regulatory and technical writing skills.Strong knowledge of Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.Good leadership skills with the ability to motivate, coach, and mentor.Strong organizational and planning skills.Ability to exercise independent judgment.Good presentation skills.Proven ability to work on multiple projects balancing competing priorities.Additional Skills & QualificationsProven ability to establish and maintain effective working relationships.Excellent understanding of study financial management.Work Environment
This position is 100% home-based and can be located anywhere in the US.
Pay and BenefitsThe pay range for this position is $45.00 - $65.00/hr.
Eligibility requirements apply to some benefits and may depend on your job
classification and length of employment. Benefits are subject to change and may be
subject to specific elections, plan, or program terms. If eligible, the benefits
available for this temporary role may include the following:
• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a fully remote position.
Application Deadline
This position is anticipated to close on Aug 22, 2025.
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.
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.
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