Global Biotech company with US Headquarters outside Boston, MA is expanding. Looking for Dynamic Leader to work remotely (possible meetings and functions each quarter in Waltham, MA office)
The AD, Monitoring Oversight is responsible for Oversight and implementing a global sponsor oversight monitoring program within the clinical operations department. This person will report to the Head of clinical Operations. The sponsor oversight monitoring role plays a significant contribution to the clinical quality risk management strategy for the Company clinical programs. The senior manager of global monitoring oversight will lead internal process improvements related to monitoring quality and data integrity to ensure programs are executed with high quality standards in compliance with regulatory requirements, GCP, and company SOPs.
This role reflects the knowledge, experience, skill levels and capacity to manage complex studies or programs. The level of the position of Senior Manager or Associate Director will be determined based on candidates experience level.
Responsibilities:
• Responsible/Accountable for the management of global oversight monitoring for the Company sponsored clinical studies or programs, ensuring monitoring oversight quality is following SOPs, regulations and ICH/GCP guidelines.
• Provide leadership, mentorship, and line management to a global sponsor oversight monitoring team of Company oversight monitors (also known as sponsor CRAs).
• Partner with team, CRO and cross-function teams to facilitate improved clinical quality and monitoring activities.
• Ensure site training/communications are occurring as needed.
• Develops strong, collaborative working relationships with CROs/vendors, key investigators, and other key staff.
• Provide recommend and implement risk mitigation strategies to ensure proactive management of protocol/GCP compliance and data quality by the CRO and investigator sites.
• Establish oversight monitoring performance metrics to ensure consistency of delivery of the global oversight monitors across the department.
• Point of escalation for site and CRO quality performance concerns, data quality risks and GCP non-conformities identified through sponsor oversight monitoring visits.
• Ensures timely responses to clinical site staff and all regulatory agencies.
• Manage site and study CAPAs to the quality resolution and closure and implement preventative risk mitigations and CAPA effectiveness checks.
• Develop oversight monitoring guidance documents such as the co-monitoring plan, vendor oversight plan, global monitoring tools and templates, etc.
• Perform quality review checks on key clinical documents such as clinical protocols, informed consent forms, case report forms, clinical monitoring plan, monitoring reports, etc.
• Share best practice from monitors/regions to raise the quality of data and protocol compliance at all sites.
• Perform oversight Monitor quality control visits (yearly or as needed).
• Support of Clinical Operations projects, infrastructure, training, and processes (e.g. SOP development and review, management of clinical systems, oversight of clinical metrics tracking and reporting), inspection readiness efforts and audit-ready Trial Master Files reviews (internal and at CRO).
• Travel required: up to 40%
Requirements
Requirements
• BA/BS degree in Health or Life Sciences required, advanced degree preferred.
• A minimum of 7+ years of experience in Clinical Operations roles within the Pharmaceutical and/or Medical Device Industry, with heavy concentration within clinical trial management and monitoring.
• A minimum of 2+ years of experience as a manager/leader
• A minimum of 3+ years of experience as a field monitor with a Pharmaceutical/Medical Device company or CRO.
• Exceptional collaboration, communication, and interpersonal skills
• Demonstrated ability to effectively manage external vendors & CROs
• Advanced proficiency in Microsoft Office and Microsoft Project or Smartsheets
• Reliable, self-motivated, team player
• Detail oriented with excellent organizational skills
• Ability to effectively manage multiple tasks and competing priorities