Clinical Research Program Manager II

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 whats 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 Integras Global Clinical Affairs team.

To perform this job successfully an individual must be able to perform each essential duty satisfactorily.
Coordinates clinical operations including: Design initiation coordination of clinical trials to support regulatory submissions as well as postmarket clinical trials. In case of CRO managed studies: Leads CRO evaluation and selection process and provides ongoing CRO oversight.
Coordinates the preparation of stateoftheart study documentation including: protocol statistical data analysis plan monitoring plan informed consent form case report form investigator agreement and financial agreement as required.
Ensures compliance with all applicable regulatory standards related to clinical trials and interactions with physicians. Continues to increase knowledge of medical device development process ICHGCP FDA regulations and any other applicable local/international regulatory requirements.
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.
Responsible for the financial management of the clinical trial program including budget planning
resource allocation preparation of quarterly reports and investigator payments as applicable.
Plans and manages study site activities and provides ongoing updates of site status to management.
Supports data collection assessment and reporting activities. Works closely with Data Management for
the design and of appropriate data management practices including the use of electronic data
capture (EDC) and clinical trial management systems (CTMS).
Works collaboratively with Medical Writers for the writing and editing of manuscripts protocols
IDE submissions CSRs outlines tables and figures for clinical publications.
Anticipates/identifies potential problems and implements corrective actions on clinical trials.
Participates in quality improvement efforts to increase overall operational efficiency of the
clinical operations team.
Interfaces with Global Clinical Affairs Legal R&D Marketing and Sales to ensure that clinical activities
are in line with overall strategic goals.
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.
Represents the company at conferences regulatory meetings and relevant trade associations.
Accurately completes administrative activities in a timely manner.
Ability to travel 20 of time.

Qualifications:

Education: Bachelors Degree in LifeSciences 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:
Strong interpersonal verbal and written communication skills. Ability to form strong and
constructive internal as well as external professional relationships.
Detail oriented excellent organizational and management skills.
Position requires composition ability data analysis skills scientific writing and presentation skills
Experience in applied science leadership skills and ability to merge science with business goals
preferred.
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.
Experience in the use of electronic data managements systems.
Experience in collaborations with relevant trade organizations as well as hospitals and physicians.
Effectively interacts with and collaborates at all levels in the organization including effective
interface at the senior management level.
Must be computer literate with working knowledge of Microsoft Office.
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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