Integra LifeSciences Clinical Quality Systems Lead 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.
Founded in 1989 Integra is headquartered in Plainsboro, New Jersey and has more than 4,000 employees worldwide. Integra’s common stock is listed on The NASDAQ Stock Market under the symbol “IART.”
Reporting into the Director, Clinical Operations, the Clinical Quality Systems Lead will work proactively and collaboratively with Clinical Operations colleagues to ensure the successful delivery of high quality clinical studies aligned with Good Clinical Practices (GCP) and applicable regulations. The Clinical Quality Systems Lead will also be responsible for managing select clinical systems to improve quality and overall performance in Clinical Operations. Further, this individual will work in collaboration with members of Global Quality Assurance to ensure organizational alignment with the Quality Management System (QMS) and sharing of better practices in support of the QMS. By fulfilling these responsibilities, the individual will aid in ensuring the high-quality execution of clinical studies/programs in adherence to business plans.
ESSENTIAL DUTIES AND RESPONSIBILITIES
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily:
Clinical Quality Assurance:
Plan and conduct audits related to clinical studies including, but not limited to, clinical vendor audits, study site Quality Assurance audits, Trial Master File (TMF) audits, and site and sponsor pre-inspection preparation. Certain types of audits (e.g. clinical vendor audits) may be conducted under the supervision of or in conjunction with Global Quality Assurance, as applicable.
Identify trends that could improve the quality of clinical studies. Identified trends should be reported to department management on at least a quarterly basis for development of Corrective And Preventative Actions (CAPA), as applicable.
Administrate activities surrounding Clinical Operations Standard Operating Procedures (SOPs) including, but not limited to, ensuring SOP curricula for roles within Clinical Operations are current and accurate, driving the timely completion of SOP updates, and coordinating required departmental SOP training completion.
Work with the Corporate Quality Subject Matter Experts (SME) in systems (e.g. Agile) and processes to ensure Clinical Operations compliance. Requires developing strong partnerships with Global Quality Assurance.
Clinical System Administration:
Act as System Administrator for electronic Trial Master File (eTMF) and Clinical Trial Management System (CTMS) to ensure appropriate accesses are granted and maintained for clinical study personnel.
Develop and keep current durable training materials for the eTMF and CTMS. Conduct system training sessions to ensure both current staff and new hires have working knowledge of clinical systems.
Act as principal source of information for clinical systems such as eTMF and CTMS.
Assist in development of quality and performance metrics related to clinical systems such as eTMF and CTMS. Assist in developing reporting for established quality and performance metrics.
Conduct monthly CTMS and eTMF data entry quality checks to ensure complete and current information can be extracted from clinical systems at all times.
Database Quality Review:
Assist in development and maintenance of clinical database/Electronic Data Capture (EDC) User Acceptance Testing (UAT) processes.
Assist in development and maintenance of durable training materials for the EDC UAT process. Assist in conducting training sessions to ensure both current staff and new hires have working knowledge of EDC UAT process.
Participate in the transformation of clinical study protocol data requirements into clear and accurate Case Report Forms (CRFs). Assist in subsequent data base specification development including, but not limited to, refining logic for edit checks and identifying interrelated CRF fields.
Participate in clinical study EDC UAT to ensure quality of released databases.
Assist in clinical study EDC training for appropriate staff (e.g. Clinical Research Associates).
Coordination, Communication, and Administration:
Support and communicate functional, departmental or organizational initiatives.
Support the identification of training gaps within Clinical Affairs functions, support the development of training materials to meet that gap, and provides training as required to improve core competency and skill set of the department.
Lead or participate in quality and continuous improvement efforts to increase overall effectiveness of the Clinical Operations team.
Interface with other departments (Quality, Legal, Regulatory, R&D) to represent the clinical department and ensure effective inter-department communication and collaboration.
Represent the company at conferences, regulatory meetings, and relevant trade associations.
Accurately complete administrative activities such as time reporting and expense reporting in a timely and accurate manner.
Complete other assignments and responsibilities as required.
DESIRED MINIMUM QUALIFICATIONS
The requirements listed below are representative of the knowledge, skill, and/or ability required for this position:
Bachelor’s Degree or equivalent experience in LifeSciences, Pharmaceutical, or related field required. Advanced degree is a plus.
A minimum of three to five 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 Clinical Quality Assurance experience or related equivalent experience required.
Demonstrated analytical, negotiation, documentation, meeting management, and leadership skills are required.
Demonstrated knowledge of clinical quality assurance processes including, but not limited to, planning and conduct of site and vendor audits, Good Clinical Practices (GCP), Good Documentation Practices (GDP), and Quality Management Systems (QMS) is required.
Demonstrated ability to effectively interact with and collaborate at all levels in the organization and with external stakeholders, 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, 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 design and development of quality plans and audit plans preferred.
Thorough knowledge of FDA guidelines and regulations, ICH guidelines and Good Clinical Practices (GCP) governing the conduct of clinical trials required.
Must be computer literate with working knowledge of Microsoft Office
Ability to travel 25% to 50% of time. Domestic and/or International travel required.
Vacancy ID 2018-27847
Position Type Regular Full-Time
Category Clinical Affairs
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 stat