Integra LifeSciences Manager, Clinical Research in Plainsboro, New Jersey
Integra LifeSciences, a world leader in medical technology, is dedicated to limiting uncertainty for surgeons, so they can concentrate on providing the best patient care. Integra offers innovative solutions in orthopedic extremity surgery, neurosurgery, reconstructive and general surgery, and regenerative wound care.
Integra's orthopedic products include devices and implants for foot and ankle, hand and wrist, shoulder and elbow, tendon and peripheral nerve protection and repair. Integra is a leader in neurosurgery, offering a broad portfolio of implants, devices, instruments and systems used in neurosurgery, neuromonitoring, neurotrauma, and related critical care. Integra’s Tissue Technologies is an in-patient and outpatient Regenerative product portfolio, which includes products for wound care, burns, abdominal reconstruction, and plastic & reconstructive surgery. In the United States, Integra is a leading provider of surgical instruments to hospitals, surgery centers and alternate care sites, including physician and dental offices.
Founded in 1989 Integra is headquartered in Plainsboro, New Jersey and has over 4,500 employees worldwide. Integra's common stock is listed on The NASDAQ Stock Market under the symbol "IART."
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 the leadership of Integra’s Global Clinical Affairs team and in accordance with Good Clinical Practice (GCP), ICH Guidelines, and applicable federal or national regulations. They are responsible for the operational and financial management of clinical study planning and execution for assigned projects and leadership of the Study Core Team. Close collaboration with stakeholders within Clinical Affairs and across various business functions is required
ESSENTIAL DUTIES AND RESPONSIBILITIES
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
Budget and Contract Coordination:
Ensures project budget is developed and managed in line with organizational expectations, including the development of appropriate site budgets
Responsible for the financial management of the clinical trial program including budget planning, resource allocation, preparation of quarterly reports and investigator payments as applicable
Leads clinical operations including: Design, initiation, coordination of clinical studies 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. Accountable for all project timelines and deliverables
Accountable for all aspects of vendor management for assigned studies and responsible for driving vendors to complete their activities in accordance with contracted terms
Coordinates the preparation of state-of-the-art study documentation by leveraging cross-functional resources and their expertise. Documentation may include, but is not limited to, protocol, statistical data analysis plan, monitoring plan, informed consent form, case report form, investigator agreement and financial agreement, as required.
Leads Study Core Team meetings to ensure appropriate decision making and transparency with stakeholders within Clinical Affairs and the business
Evaluates and communicates the probability and impact of risks, develops quality and risk management plans, and ensures integration into the overall management of the project to ensure delivery consistent with the project plan
Oversees the development of the eCRF or CRF as appropriate
Oversees the feasibility and site selection process through collaboration across Clinical Affairs and with key stakeholders. Remains accountable for the final determination of the study site list from the site selection process
Leads preparation and provides input into materials for Investigator Meetings, Initiation Visits, Training Meetings, and similar study related activities
Coordinates and holds responsibility for ensuring that all data pertaining to study status is compiled and reported monthly as appropriate
Ensures compliance with all applicable regulatory standards related to clinical studies and interactions with physicians. Continues to increase knowledge of medical device development process, ICH-GCP and applicable FDA and local/international regulatory requirements
Leads the planning and management of 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 execution of appropriate data management practices, including the use of electronic data capture (EDC)
Ensures timely entry of clinical study information into the clinical trial management systems (CTMS), eTMF, EDC, www.clinicaltrials.gov and other relevant systems to create transparency into study progress and activity
Works collaboratively with Medical Writers for the writing and editing of manuscripts, protocols, IDE submissions, CSRs, outlines, tables, and figures for clinical publications
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.
Anticipates/identifies potential problems and implements corrective actions on clinical trials
Departmental Management and Staff Development:
Responsible for ensuring that staff are consistently driving and partnering with the project teams to ensure transparency and partnership structure that assures the appropriate updates are provided, that performance is to their expectations, and that there is clear understanding of expectations as a project team member from the function to ensure the success of a matrix management structure
Exhibits active mentorship of study team to build talent across the department
Exhibits active leadership in project teams
Actively follows and manages the application and communication of all Integra policies, procedures, and Values and helps to instill in all staff across Clinical Operations
Coordination, Communication and Administration:
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
Supports and communicates functional, departmental or organizational initiatives
Supports the identification of training gaps within Clinical Affairs functions, supports the development of training materials to meet that gap, and provides training as required to improve core competency and skill set of the department
Supports the maintenance of guidelines, training programs, policies and procedures
Ensures compliance with the application and communication of all Integra policies, procedures and values within the matrixed team
Ensures that all team members understand and work towards corporate and department goals
Ensures that all team members understand the priorities of the business, that they are focused on those priorities and that their level of accountability is understood and accepted within a matrix environment
Leads or participates in quality and continuous improvement efforts to increase overall effectiveness 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.
Represents the company at conferences, regulatory meetings, and relevant trade associations
Accurately completes administrative activities such as time reporting and expense reporting in a timely and accurate manner
Ability to travel 20% to 50% of time.
Works with department staff to support and achieve department objectives.
Works with Global Clinical Affairs members at other location to coordinate and streamline clinical operations worldwide.
Interfaces with other departments (R&D, Marketing, Sales, Legal, Regulatory, Quality) to represent the clinical department and ensure effective inter-department communication and collaboration.
Works closely to establish collaborative relationship with KOLs and/or clinical trial investigators.
The requirements listed below are representative of the knowledge, skill and/or ability required for this position:
Bachelor’s Degree in LifeSciences, Pharmaceutical or related Sciences required. Advanced degree (PhD, PharmD, MPH, MBA, ...) is a plus.
A minimum of five to seven years’ of progressively responsible experience in clinical research within a medical device, pharmaceutical, biotechnology, CRO, and/or healthcare setting required. ̣ A minimum of one year on-site monitoring experience or related equivalent experience required. International study management experience is preferred.
Demonstrated analytical, negotiation, meeting management, cross-functional team and leadership skills at a management level are required
Demonstrated ability to effectively interact with and collaborate at all levels in the organization, including effective interfaces at the senior management level
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
Must have the demonstrated core understanding of medical terminology and clinical trial activities in relation to execution of a clinical development plan
Experience in applied science, leadership skills and ability to merge science with business goals preferred.
Experience in design and development of scientific research protocols, clinical investigational plans, and regulatory strategies preferred
Thorough knowledge of FDA guidelines and regulations, ICH guidelines and Good Clinical Practices (GCP) governing the conduct of clinical trials required
Experience in collaborations with relevant trade organizations, as well as hospitals and physicians preferred
Must be computer literate with working knowledge of Microsoft Office
Project management certification or relevant experience is a plus
Vacancy ID 2018-26719
Position Type Regular Full-Time
Category Clinical Affairs