Abbott Manager Clinical Compliance, IVD Diagnostics and Medical Devices in Des Plaines, Illinois

At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.

Summary

Lead compliance efforts of the division related to clinical research. Prepares and monitors internal and external audits of clinical studies. Lead development, implementation and tracking of AMD clinical affairs programs against federal and international guidelines.

Support Abbott Molecular Diagnostics Clinical Affairs Team in developing, implementing and tracking of compliance program standards as well as local and worldwide regulations and guidelines (i.e.

Good Clinical Practice (GCP), International Conference of Harmonization (ICH), and Food and Drug Administration (FDA)) Provide GCP supervision and guidance for clinical research activities by collaborating with various internal and external groups (Regulatory, Statistics and study/site managers) Maintain a high level of quality and consistency across the clinical programs Provide guidance to clinical teams on best practices, industry standards and regulations Encourage discussion and evaluate best practices for continuous improvement of quality and compliance across programs Prepare and assist / monitor required actions for both for internal audits (AMD) and external audits Bioresearch Monitoring (BIMO) / FDA and other Notified Bodies Oversee audit plans, audit reports and institute any necessary corrective or preventative actions to meet procedural or regulatory compliance requirements Review protocol and clinical trial registration documentation for accuracy, completeness and compliance requirements Oversee and review adverse events reporting as per company procedures and regulatory requirements.

Responsibilities

  • Manage the safety program of all of AM’s clinical trials, which includes the assessment of all AEs, SAEs for reportability and for those that require adjudication

  • Periodic reporting of safety data to clinical affairs and to management

  • Training of clinical trial GCP compliance to clinical project managers and clinical research monitors, with regards to safety, and compliance procedures

  • Review all aspects of clinical study safety programs, including preparation of case report forms, study reports and data management plans

  • Ensure final accuracy of all clinical trials’ safety data and its timely availability

  • Oversee all GCP compliance issues and assure appropriate communication, issue resolution and adherence to SOPs and guidelines

  • Develop and implement the appropriate safety and compliance procedures for AM’s clinical trials, including staff and contractor training

  • Support site qualification, site initiation, monitoring, site close out activities, by reviewing respective reports in accordance with clinical safety and compliance procedures

  • Work closely with Regulatory Affairs in the generation of FDA’s Annual Progress Reports as well as safety reports as required by the IRB or EC, Ministry of Health, and other governing agencies

  • May conduct periodic audits of clinical vendors including laboratories, hospitals, and clinical research organizations

  • Provide leadership, direction and accountability for GCP related corrective and preventive action plans that result from audit findings by working with audit teams and auditees to resolve any conflicts; report GCP inspection outcomes; track audit commitments and provide metric reports to Upper Management

  • Perform GCP internal audits of the clinical TMF and clinical site files

  • Host external regulatory audits from FDA, WHO, notified bodies, and ISO

  • Demonstrate strong interpersonal and social skills

  • Demonstrate the ability to independently identify GCP compliance issues and generate resolutions

  • May be asked to perform other Clinical responsibilities as needed

Additional Responsibilities

  • Serve as GCP subject matter expert to the division and primary compliance liaison to cross-functional business leaders including Quality, Regulatory, R&D, Statistics, Medical Affairs, and Legal.

  • Participate in monthly compliance consortium meetings. Share audit learnings and baseline with other Abbott divisions regarding audits and procedures

  • Perform CAPA investigations and implement corrective actions

  • Oversee training records and personnel qualifications to ensure clinical team is qualified to perform ongoing work

Accountability

Accountable for maintaining essential documents associated with ADD clinical research in a compliant fashion. Complete, compliant files are required as documentation of well-controlled clinical studies and are essential for regulatory submissions of ADD products.

Qualifications

Bachelors degree in scientific or technical discipline is required. Degree in healthcare or medical field is preferred. Minimum 5 years in performing clinical research or similar work experience in the medical device field audit experience preferred). Clinical research experience in both PMA and 510(k) products is desired. In-depth knowledge of the US federal and international regulations related to clinical research. Proven record of compliance to regulations and guidelines such as Code of Federal Regulation (CFRs), GCPs, ICH guidelines and FDA regulations in clinical studies

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email corpjat@abbott.com