Job Description

Responsible for planning, setting up, managing, executing, and overseeing RWE projects from start to finish. Ensure projects are delivered on time, within budget, and meet all quality standards. Coordinate teams, manage resources, mitigate risks, and communicate effectively with stakeholders across various departments and levels. Act as the central point of contact to guide a project through its lifecycle, adapting to changing circumstances and challenges in a practical, hands-on manner.

Responsibilities

• Manage initiation and start-up of RWE studies, including negotiating and finalizing site contracts and budgets.

• Assemble and lead a cross-functional team, assigning tasks, delegating responsibilities, and monitoring individual performance.

• Identify and manage project resources (personnel, budget, technology) to optimize efficiency and ensure timely completion.

• Proactively identify potential risks, develop mitigation strategies, and track their impact on the project.

• Regularly communicate project status updates to key stakeholders (clients, internal team members) through meetings, reports, and other channels.

• Implement quality assurance measures to ensure project deliverables meet established standards.

• Adapt to project scope changes, manage revisions, and communicate updates to the team and stakeholders.

• Track project progress against the plan, identify deviations, and take corrective actions to stay on track.

• Finalize project deliverables, document lessons learned, and conduct post-project evaluations.

• Negotiate contracts with sites based in the US.

• Ensure adherence to good clinical practice (GCP), standard operating procedures (SOPs), work instructions (WIs), quality of designated deliverables, and project timelines.

• Perform regulatory, start-up, and maintenance activities according to applicable regulations, SOPs, and work instructions.

• Distribute completed documents to sites and internal project team members.

• Prepare site regulatory documents, reviewing for completeness and accuracy.

• Review, prepare, and negotiate site contracts and budgets with sites, where applicable.

• Ensure accurate completion and maintenance of internal systems, databases, and tracking tools with project-specific information.

• Review and provide feedback to management on site performance metrics.

• Review, establish, and agree on project planning and project timelines. Ensure monitoring measures are in place and implement contingency plans as needed.

• Inform team members of the completion of regulatory and contractual documents for individual sites.

• Review, track, and follow up on the progress, approval, and execution of documents, including contracts, regulatory/ethics submissions, and ICF adaptation and negotiation, in line with project timelines.

• Provide local expertise to the Clinical Operations Lead and project team during initial and ongoing project timelines planning.

• Perform quality control of documents provided by sites.

• May have direct contact with sponsors on specific initiatives.

• May perform site selection visits if a trained monitor.

• May participate in feasibility and/or site identification activities.

Additional Skills & Qualifications

• Minimum of 5 years of clinical experience required.

• Equivalent combination of education, training, and experience may be acceptable.

• Knowledge of clinical research process and medical terminology.

Work Environment

Remote home-based role with a preference for candidates in the US Eastern Standard Time (EST) zone.

Pay and Benefits

The pay range for this position is $55.00 - $70.00

• 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 will be accepting applications until Dec 16, 2024.

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.