Clinical Project Research Manager – EDS, RWE, NIS

This is a fully remote position, open to applicants in United States.

📋 Description

• Plan, organize, and guide UBC project teams to successfully deliver projects aligned with client requirements, ensuring timely completion, budget adherence, and scope management.

• Oversee all facets of project execution, from initiation to closure.

• Execute the operational components of assigned project activities and special initiatives.

• Manage projects according to the defined scope of work and contractual budget.

• Handle project revenue and invoicing processes.

• Ensure adherence to UBC and relevant client Standard Operating Procedures (SOPs).

• Develop project plans and processes to meet agreed-upon milestones.

• Monitor project progress and ensure compliance with established plans.

• Prepare project timelines and coordinate deliverables effectively.

• Draft meeting agendas, minutes, and action logs.

• Track project budgets against contract milestones.

• Act as UBC’s primary point of contact for sponsors.

• Organize project meetings with both internal and external stakeholders.

• Address questions raised by project team members.

• Supervise functional areas that support projects.

• Lead cross-functional project initiatives.

• Ensure and facilitate project training.

• Develop and conduct internal and external kick-off meetings.

• Negotiate budgets and assist in contract remediation efforts.

• Present project information during bid defenses, client meetings, and monthly project reviews.

• Maintain documentation that is audit-ready for projects.

• Participate in sponsor and regulatory audits.

• Coordinate investigator meetings.

• Assist in the development of protocols and patient/subject consent forms or REMS documents as needed.

• Lead initiatives for process improvement.

• Establish, implement, and monitor key project metrics.

• Oversee the upkeep of the Trial Master File.

• Perform Clinical Study Specialist (CSS) and Clinical Research Associate (CRA) duties as necessary.

• Carry out other responsibilities as assigned by management.

• Supervise the project team.

⛳️ Requirements

• Bachelor's Degree or equivalent experience is required.

• Previous managerial or relevant experience is essential.

• Exceptional written, verbal, and non-verbal communication abilities.

• Strong supervisory, interpersonal, and presentation skills.

• Capability to independently evaluate issues and mitigate risks using critical judgment to reach resolutions.

• Solution-oriented mindset.

• Familiarity with regulatory requirements (i.e., Good Clinical Practice, ICH guidelines, etc.).

• Willingness to travel up to 10% as required.

🏝️ Benefits

• Opportunities for remote work.

• Competitive salary packages.

• Opportunities for career advancement.

• 401K plan with company matching contributions.

• Tuition reimbursement programs.

• Flexible work environment.

• Discretionary Time Off.

• Paid holidays.

• Employee assistance programs.

• Comprehensive medical, dental, and vision coverage.

• Health Savings Account (HSA)/Flexible Spending Account (FSA).

• Telemedicine options (virtual doctor appointments).

• Wellness initiatives.

• Adoption assistance programs.

• Short-term disability insurance.

• Long-term disability insurance.

• Life insurance coverage.

• Various discount programs.