Clinical Research Program Manager II

Integra LifeSciences Corporation; Princeton (NJ); Hybrid; USD 80,000 - 120,000; Full time

Job summary

An established industry player is seeking a Clinical Research Manager to lead innovative clinical projects that shape the future of healthcare. This dynamic role involves coordinating clinical operations, ensuring compliance with regulatory standards, and managing financial aspects of clinical trials. The ideal candidate will have a strong background in clinical research, exceptional communication skills, and the ability to work collaboratively across departments. This position offers a unique opportunity to make a significant impact in the medical device field while working in a hybrid environment, balancing office days with remote work. Join a forward-thinking company that values innovation and excellence in patient care.

Qualifications

• 5-7 years of clinical research experience in medical device or pharmaceutical industry.
• Strong skills in communication, organization, and scientific writing are essential.

Responsibilities

• Coordinate clinical trials, ensuring compliance with regulatory standards.
• Manage financial aspects of clinical trial programs and support data collection.

Skills

Interpersonal Skills

Communication Skills

Organizational Skills

Data Analysis Skills

Scientific Writing

Leadership Skills

Project Management

Education

Bachelor's Degree in Life Sciences

Advanced Degree (PhD, PharmD, MPH, MBA)

Tools

Electronic Data Capture (EDC)

Clinical Trial Management Systems (CTMS)

Microsoft Office

Job description

Changing lives. Building Careers.

Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.

The Clinical Research Manager is responsible for all aspects of clinical study operations for assigned Integra LifeSciences clinical projects according to the strategy defined by leadership of Integra’s Global Clinical Affairs team.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

1. Coordinates clinical operations including: Design, initiation, coordination of clinical trials to support regulatory submissions, as well as post-market clinical trials. In case of CRO managed studies: Leads CRO evaluation and selection process and provides ongoing CRO oversight.
2. Coordinates the preparation of state-of-the-art study documentation, including: protocol, statistical data analysis plan, monitoring plan, informed consent form, case report form, investigator agreement and financial agreement, as required.
3. Ensures compliance with all applicable regulatory standards related to clinical trials and interactions with physicians. Continues to increase knowledge of medical device development process, ICH-GCP, FDA regulations and any other applicable local/international regulatory requirements.
4. Assists in updating corporate Standard Operating Procedures (SOPs) to support adherence to company policies and procedures concerning Clinical Affairs, in coordination with Global Clinical Affairs team members.
5. Responsible for the financial management of the clinical trial program including budget planning, resource allocation preparation of quarterly reports and investigator payments as applicable.
6. Plans and manages study site activities and provides ongoing updates of site status to management.
7. Supports data collection, assessment and reporting activities. Works closely with Data Management for the design and execution of appropriate data management practices, including the use of electronic data capture (EDC), and clinical trial management systems (CTMS).
8. Works collaboratively with Medical Writers for the writing and editing of manuscripts, protocols, IDE submissions, CSRs, outlines, tables, and figures for clinical publications.
9. Anticipates/identifies potential problems and implements corrective actions on clinical trials.
10. Participates in quality improvement efforts to increase overall operational efficiency of the clinical operations team.
11. Interfaces with Global Clinical Affairs, Legal, R&D, Marketing and Sales to ensure that clinical activities are in line with overall strategic goals.
12. Supports regulatory affairs personnel with clinical sections of regulatory submissions, and study related communication with regulatory agencies. Collects, reviews and tracks regulatory documents when required.
13. Represents the company at conferences, regulatory meetings, and relevant trade associations.
14. Accurately completes administrative activities in a timely manner.
15. Ability to travel 20% of time.

Qualifications:

Education: Bachelor’s Degree in Life Sciences, Pharmaceutical or related Sciences required. Advanced degree (PhD, PharmD, MPH, MBA, ...) is a plus.

Experience: Five to seven years’ experience in clinical research required, preferably in medical device industry. Proven track record of conducting clinical research studies in a hospital setting, medical device and/or pharmaceutical company, or CRO.

Specific competencies:

1. Strong interpersonal, verbal and written communication skills. Ability to form strong and constructive internal as well as external professional relationships.
2. Detail oriented, excellent organizational and management skills.
3. Position requires composition ability, data analysis skills, scientific writing and presentation skills.
4. Experience in applied science, leadership skills and ability to merge science with business goals preferred.
5. Expert in design and development of scientific research protocols, clinical investigational plans, and regulatory strategies. Thorough knowledge of FDA guidelines and regulations, ICH guidelines and Good Clinical Practices (GCP) governing the conduct of clinical trials.
6. Experience in the use of electronic data management systems.
7. Experience in collaborations with relevant trade organizations, as well as hospitals and physicians.
8. Effectively interacts with and collaborates at all levels in the organization, including effective interface at the senior management level.
9. Must be computer literate with working knowledge of Microsoft Office.
10. Project management certification or relevant experience is a plus.

Additional details:

This role is hybrid between Princeton, NJ and remote. Office days are Tuesday, Wednesday and Thursday.

Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.

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