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Job #03128

About our client Our client is a worldwide leader in orthopedics and has been very innovative since its founding more than 75 years ago. Their hip and knee joint replacement systems and wide range of related products and services make our client valuable partners to health care providers in 100 countries. This is an exciting opportunity for the right person to join a stimulating work environment focused on being the best – designing and building the best possible systems and delivering the best package of value-added services for their customers. Position Location Clinical compliance Manager Warsaw, Indiana Salary Highly competitive package, commensurate with experience Responsibilities 1) Support Global Clinical Affairs Team in developing, implementing and tracking of company's compliance program standards as well as federal regulations and guidelines (i.e. GCP, ICH, BSI and FDA) 2) Provide GCP supervision and guidance for clinical research activities by collaborating with various internal and external groups (Data Management, Regulatory, Medical Writing, Biostatistics and study/site managers) 3) Maintain a high level of quality and consistency across the clinical programs 4) Provide guidance to clinical teams on best practices, industry standards and regulations 5) Foster relationships with Clinical Research staff 6) Encourage discussion and evaluate best practices for continuous improvement of quality and compliance across programs 7) Oversee Clinical Compliance staff in Warsaw and assume dotted line accountability for compliance associates at remote offices 8) Provide clinical compliance guidance and consultation to senior management at all clinical affairs locations 9) Evaluate the company needs to establish a first class clinical compliance group 10) Take the lead to internally build the appropriate organization 11) Oversee the surgeon selection and approval process to continue refining the HCP selection criteria 12) Work with Compliance and Legal as well as oversee to expedite the selection and contracting process 13) Ensure that all required documents are available at all reviews 14) Collaborate with Compliance Office to ensure analysis as well as report support DPA and CIA requirements 15) Establish and implement a compliance training plan 16) Direct and/or conduct formal compliance and GCP/ICH trainings 17) Develop internal company procedures to meet GCP compliance requirements 18) Initiate and oversee appropriate internal department and external clinical site audits 19) Prepare SOPs for the clinical compliance function 20) Oversee audit plans, audit reports and institute any necessary corrective or preventative actions to meet procedural or regulatory compliance requirements 21) Initiate follow-up assessments to ensure compliance 22) Participate in the HCP payment process to ensure that all compliance criteria are being met prior to payment requests 23) Review protocol and clinical trial registration documentation for accuracy, completeness and compliance requirements 24) Lead risk assessment and risk mitigation of clinical development projects from a quality perspective 25) Institute any process improvement initiatives necessary across the organization 26) Work with the Research Services Manager in developing systems to request and track quarterly research reports and collaborate with the External Research Division to ensure study progress 27) Oversee and review adverse events reporting as per company procedures and regulatory requirements 28) Ensure team is complying with Title 21 CFR Part 803 Subpart C "Medical Device Reporting – User Facility Reporting Requirements" 29) Perform other duties as assigned Requirements 1) Bachelor’s/Advanced degree (scientific/healthcare field preferred) with extensive clinical research experience 2) Minimum 5 – 7 years in performing clinical research (auditing experience preferred) 3) Previous supervisory experience preferred 4) In-depth knowledge of the US federal regulations related to clinical research (21 Parts 50, 56, 312, 812 and ICH Good Clinical Practice guidelines) 5) Ability to review clinical protocols, informed consents, monitoring and data management plans and independently make recommendations for improvement 6) Excellent communication, training and written skills 7) Ability to present well-structured assessments to senior management, internal and external groups 8) Ability to promote teamwork demonstrating excellent interpersonal skills 9) Expertise in application of CFRs, GCPs, ISO, ICH guidelines and FDA regulations for post market outcomes and IDE/IND clinical studies 10) Experience in company ZWIs and SOPs as they apply to HCP interactions and clinical study management 11) Knowledge of product lines and departments within the company 12) Proficiency in MS Office, Internet Explorer, Livelink, JDE and other required software 13) Excellent communication skills (oral and written) 14) Willingness to travel (up to 30% with potential for international travel)