Manager, Clinical Research.US-PCO.421

Employer
Integra LifeSciences
Location
Princeton, NJ
Posted
Jul 26, 2021
Closes
Jul 31, 2021
Ref
2330766767
Sector
Other
Organization Type
Corporate
Overview:
Integra LifeSciencesis a global leader in regenerative technologies and neurosurgical solutions dedicated to limiting uncertainty for clinicians, so they can focus on providing the best patient care.Founded in 1989, Integra develops, manufactures, sells and supplies best-in-class products to regenerate tissue, remove brain tumors, prevent infection and much more. And over the last three decades, weve evolved into one of the worlds leading global medical technology companies with more than 4,000 dedicated employees who deliver innovative medical technology solutions.But thats just the beginning.Integra is growing at an unprecedented rate. Were at a moment in time where the experience youll gain is more robust than the experience you bring. And were out to invest in your future because its the best way to maximize ours.

Responsibilities:
SUMMARY DESCRIPTIONThe 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 Integras 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.SUPERVISION RECEIVEDUnder direct supervision of Director, Clinical AffairsSUPERVISION EXERCISEDMatrix management of CTAs / CRAs / Sr CRAs and other Study Core Team members as required on assigned projectsESSENTIAL DUTIES AND RESPONSIBILITIESTo 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 applicableProject Management: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 deliverablesAccountable for all aspects of vendor management for assigned studies and responsible for driving vendors to complete their activities in accordance with contracted termsCoordinates 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 businessEvaluates 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 planOversees the development of the eCRF or CRF as appropriateOversees 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 processLeads preparation and provides input into materials for Investigator Meetings, Initiation Visits, Training Meetings, and similar study related activitiesCoordinates and holds responsibility for ensuring that all data pertaining to study status is compiled and reported monthly as appropriateEnsures 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 requirementsLeads the planning and management of study site activities and provides ongoing updates of site status to managementSupports 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 activityWorks collaboratively with Medical Writers for the writing and editing of manuscripts, protocols, IDE submissions, CSRs, outlines, tables, and figures for clinical publicationsSupports 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 trialsDepartmental 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 structureExhibits active mentorship of study team to build talent across the departmentExhibits active leadership in project teamsActively follows and manages the application and communication of all Integra policies, procedures, and Values and helps to instill in all staff across Clinical OperationsCoordination, 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 initiativesSupports 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 departmentSupports 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 teamEnsures that all team members understand and work towards corporate and department goalsEnsures 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 environmentLeads or participates in quality and continuous improvement efforts to increase overall effectiveness of the Clinical Operations teamInterfaces with Global Clinical Affairs, Legal, R, 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 associationsAccurately completes administrative activities such as time reporting and expense reporting in a timely and accurate mannerAbility to travel 20% to 50% of time.INTERACTIONS/RELATIONSHIPS: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, 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.

Qualifications:
POSITION SPECIFICATIONS:Education: Bachelors Degree in LifeSciences, Pharmaceutical or related Sciences required. Advanced degree (PhD, PharmD, MPH, MBA, ...) is a plus.Experience: 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 of on-site monitoring experience or related equivalent experience required. International study management experience is preferred.Specific competencies:Demonstrated analytical, negotiation, meeting management, cross-functional team and leadership skills at a management level are requiredDemonstrated ability to effectively interact with and collaborate at all levels in the organization, including effective interfaces at the senior management levelStrong interpersonal, verbal and written communication skills. Ability to form strong and constructive internal as well as external professional relationshipsDetail oriented, excellent organizational and management skillsPosition requires composition ability, data analysis skills, scientific writing and presentation skillsMust have the demonstrated core understanding of medical terminology and clinical trial activities in relation to execution of a clinical development planExperience 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 preferredThorough knowledge of FDA guidelines and regulations, ICH guidelines and Good Clinical Practices (GCP) governing the conduct of clinical trials requiredExperience in collaborations with relevant trade organizations, as well as hospitals and physicians preferredMust be computer literate with working knowledge of Microsoft OfficeProject management certification or relevant experience is a plusPHYSICAL REQUIREMENTS:The physical requirements listed in this section include, but are not limited, to the motor/physical abilities and skills require of this position in order to successfully undertake the essential duties and responsibilities of this position. In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to empower individuals with disabilities to undertake the essential duties and responsibilities of the position.While undertaking the essential duties and responsibilities of the position, the employee must repeatedly sit, listen, speak, and walk through airports etc. The employee may be required to periodically work where no special desk configurations/accommodations may be available for extended periods of time.The employee is required to go to all areas of the company and external study sites. The employee may be required to periodically lift and/or move up to 45lbs (luggage). Must be able and willing to travel (overnight) up to 50% of the time while in the position, contingent upon business needs. Ability to travel via car and/or airplane to domestic and international locations as needed.

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