Senior Clinical Project Manager

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

📋 Description

• Lead the planning and implementation of intricate IVD clinical studies.

• Create study timelines and ensure that results are delivered punctually and within budget.

• Develop clinical study protocols, informed consent documents, case report forms, and other critical paperwork.

• Formulate clinical safety plans and clinical study reports for regulatory submissions.

• Establish and monitor clinical study budgets, review and approve invoices, and manage monthly accruals.

• Supervise the study team's deliverables to ensure quality and compliance.

• Manage external vendors to guarantee that deliverables align with scope, budget, and timelines.

• Ensure adherence to company policies, FDA regulations, ISO standards, GCP, and other relevant regulations.

• Identify potential issues, suggest solutions, and document lessons learned.

• Oversee the safety of study participants through monitoring and evaluation.

• Act as a clinical study subject matter expert within cross-functional project teams.

• Develop and implement standardized clinical research processes and operating procedures.

• Create and maintain clinical study documents in the trial master file (TMF).

• Engage with investigational sites, vendors, key opinion leaders (KOLs), and consultants.

• Conduct on-site clinical monitoring activities as necessary.

• Lead and participate in cross-functional team meetings.

• Prioritize tasks to ensure project milestones are achieved or surpassed.

• Prepare and present clinical trial progress reports to key stakeholders.

• Create and maintain timely updates for clinical study registrations.

⛳️ Requirements

• Degree-level qualification; or an equivalent combination of education and experience.

• Proven experience in planning and executing complex IVD clinical studies.

• Familiarity with FDA regulations, ISO standards, Good Clinical Practice (GCP), and other applicable regulations.

• Experience in developing clinical study protocols, informed consent forms (ICFs), case report forms (CRFs), safety plans, and clinical study reports.

• Proficient in developing and tracking clinical study budgets, including invoice review/approval and monthly accrual management.

• Experience in vendor management.

• Ability to handle multiple tasks simultaneously.

• Excellent communication and project management abilities.

• Strong verbal and written communication skills.

• Capability to work independently with minimal oversight.

• Ability to collaborate as part of a diverse professional team.

• Experience with clinical study registration, including clinicaltrials.gov or global registrations.

• Ability to conduct on-site clinical monitoring activities as required.

• Capability to adhere to Waters policies, standards, and procedures.

• Ability to ensure the safety of study participants throughout the trials.

🏝️ Benefits

• Medical, dental, vision, health savings, and flexible spending accounts.

• Life and disability insurance.

• Wellness resources.

• Mental health support.

• Disease management programs.

• 401(k) plan.

• Deferred compensation programs.

• Financial counseling services.

• DailyPay options.

• Educational savings resources.

• Paid time off.

• Company holidays.

• Educational assistance.

• Parental leave.

• Adoption assistance.

• Backup care services.

• Caregiving support.

• Employee assistance programs.

• Commuter benefits.

• Pet insurance.

• Legal services.

• Associate discount programs.

• Bereavement, military, personal, family, and medical leave.

• Jury duty leave.

• Opportunities for rewards and recognition.

• Competitive compensation and benefits packages.