Clinical Compliance Manager

A leader in their industry is looking for a Clinical Compliance Manager. This position does provide full relocation, a competitive base, bonus, and stock options.Job Summary – Supports Global Clinical Affairs team in the development, implementation and tracking of Compliance Program standards as well as federal regulations and guidelines (i.e. GCP, ICH, BSI and FDA).  Provide GCP oversight and guidance for clinical research activities by collaborating with various internal and external groups (Data Management, Regulatory, Medical Writing, Biostatistics and study/site managers) to maintain a high level of quality and consistency across the clinical programs; provide guidance to clinical teams on best practices, industry standards and regulations; foster relationships with clinical research staff to encourage discussion and evaluation of best practices for continuous improvement of quality and compliance across programs.  Will oversee Clinical Compliance staff and have dotted line responsibility for compliance associates at remote offices.  General Functions –§ Provides clinical compliance guidance and consultation to senior management at all Clinical Affairs locations. § Evaluate the company needs to establish a first class clinical compliance group and take the lead to internally build the appropriate organization § In conjunction with the Study Managers, oversees the surgeon selection and approval process.  Continues to refine the HCP selection criteria.§ Works with Compliance, Legal and Oversight to expedite the selection and contracting process and ensure that all required documents are available at all reviews.  § Collaborate with Compliance Office to ensure analysis and reports support DPA and CIA requirements§ Establishes and implements a compliance training plan. Directs and/or conducts formal compliance and GCP/ICH trainings.§ Develop internal company procedures to meet GCP compliance requirements § Initiate and oversee appropriate internal department and external clinical site audits § Responsible for preparing standard operating procedures (SOPs) for the clinical compliance function§ Prepare (or oversee?) audit plans, audit reports and institute any necessary corrective or preventative actions to meet procedural or regulatory compliance requirements. Where appropriate, initiate follow-up assessments to ensure compliance § Participates in the HCP payment process to ensure that all compliance criteria are being met prior to payment requests.  § Review protocol and clinical trial registration documentation for accuracy, completeness and compliance requirements § Take a leadership role in risk assessment and risk mitigation of clinical development projects from a quality perspective § Institute any process improvement initiatives necessary across the organization § Works with Research Services Manager in developing systems to request and track quarterly research reports and collaborate with the External Research Division to ensure study progress. § Oversees and reviews adverse events reporting in accordance with company procedures and regulatory requirements.  Ensures team is complying with Title 21 CFR Part 803 Subpart C "Medical Device Reporting - User Facility Reporting Requirements." Qualifications: § Advanced degree, preferably in a scientific/healthcare field, or equivalent § Minimum of 5-7 years in performing clinical research, auditing experience preferred. § In-depth knowledge of the US Federal regulations related to clinical research ((21 Parts 50, 56, 312, 812) and ICH Good Clinical Practice Guidelines§ Ability to review clinical protocols, informed consents, monitoring and data management plans and independently make recommendations for improvements, where necessary§ Excellent communication, training and written skills with the ability to present well-structured assessments to senior management, internal and external groups§ Ability to promote teamwork demonstrating excellent interpersonal skills.  Previous supervision experience preferred.§ Other duties as assigned. This is not an exhaustive list of duties or functions and may not necessarily comprise all of the "essential functions" for purposes of the ADA Expected Areas of Competence (i.e. KSAs) – § Knowledge of and competence in application of CFRs, GCPs, ISO, ICH Guidelines and FDA Regulations for postmarket outcomes and IDE/IND clinical studies.§ Knowledge of and competence of ZWI’s and SOP’s as they apply to HCP interactions and clinical study management.§ Knowledge of product lines and departments.     Education Requirements – Bachelors, preferably in Life Science or health-related field or other degree with extensive clinical research experience. Skill Requirements – Proficient in Microsoft Office, Internet Explorer, Livelink, JDE, and other required software.  Excellent oral and written communication skills. Licenses/Certifications – None Required Travel Requirements –  30% (potential for International Travel)For immediate considerations please send Word resume to BrianMcKnight@mergisgroup.com with Clinical Compliance Manager in the subject line. Built on more than 30 years of expertise, The Mergis Group is a specialty recruiting firm committed to helping professionals make the best career choices. We connect specialized professionals to leading opportunities that will foster success in their career.