Clinical Project Manager

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

📋 Description

• Act as the study and project manager for studies of moderate to high complexity, overseeing everything from protocol development to study conduct and closeout.

• Create and write clinical research protocols that align with study objectives, regulatory needs, and scientific standards.

• Manage key study documents and keep the trial master file updated.

• Facilitate approvals and lead the final reporting and closeout activities for complex trials.

• Train and oversee CRA teams to ensure top-quality monitoring.

• Supervise external vendors, including CROs and laboratories, to ensure performance and compliance standards are met.

• Lead the development of budgets and timelines in collaboration with core teams.

• Oversee the selection and training of sites.

• Ensure effective study execution and provide status updates.

• Collaborate with clinical data management and biostatistics teams to design case report forms, support data cleaning efforts, and contribute to accurate study analysis.

• Conduct work in accordance with Good Clinical Practices and relevant national and local regulations.

⛳️ Requirements

• A Bachelor’s degree is required.

• A minimum of 3 years of recent experience in clinical study management within a pharmaceutical, device, or CRO company is necessary.

• Strong project management skills, including the utilization of a formal process and system for planning and tracking the ongoing progress of clinical projects.

• Vendor management experience is required.

• Willingness and ability to travel approximately 30% of the time, both domestically and internationally.

• Knowledge and experience with Good Clinical Practice (GCP) and ICH requirements are essential.

• Education and experience adequate to contribute within the local work unit with limited supervision.

🏝️ Benefits

• Annual Bonus

• Health and Well-being Benefits

• Medical coverage

• Health Savings Accounts

• Flexible Spending Accounts

• Dental coverage

• Vision coverage

• Hospital Care Insurance

• Critical Illness Insurance

• Accidental Injury Insurance

• Life and AD&D insurance

• Short-term disability coverage

• Long-term disability insurance

• Long-term care with life insurance

• Anxiety management program

• Wellness incentives

• Sleep improvement program

• Diabetes management program

• Virtual physical therapy

• Emotional/mental health support programs

• Weight management programs

• Gastrointestinal health program

• Substance use management program

• Benefits for musculoskeletal surgery, cancer treatment, and bariatric surgery

• BD 401(k) Plan

• BD Deferred Compensation and Restoration Plan

• 529 College Savings Plan

• Financial counseling

• Baxter Credit Union (BCU)

• Daily Pay

• College financial aid and application guidance

• Paid time off (PTO), including all mandated State leaves

• Educational assistance/tuition reimbursement

• MetLife Legal Plan

• Group auto and home insurance

• Pet insurance

• Commuter benefits

• Discounts on products and services

• Academic Achievement Scholarship

• Service Recognition Awards

• Employer matching donation

• Workplace accommodations

• Adoption assistance

• Backup daycare and eldercare

• Support for neurodivergent adults, children, and caregivers

• Caregiving assistance for elderly and special needs individuals

• Employee Assistance Program (EAP)

• Paid Parental Leave

• Support for fertility, birthing, postpartum, and age-related hormonal changes

• Bereavement leaves

• Military leave

• Personal leave

• Family and Medical Leave (FML)

• Jury and Witness Duty Leave

• Comprehensive Total Rewards program

• Reward and recognition opportunities

• Competitive compensation and benefits programs