The Clinical Operations Lead, Senior Manager (COL-SM) oversees outsourced (or CRO) start up and monitoring activities to ensure the quality execution of protocol procedures, adherence to good clinical practices (GCP) and evolving regulatory requirements, and ensure consistency of monitoring activities.
The COL-SM will be responsible for coordinating rapid start up activities across allocated countries and/or region together with the CRO
The COL-SM will ensure that the CRO monitoring study sites is resulting in the effective identification and problem solving of issues. Findings and solutions will be communicated to both Alexion and the CRO.
The COL-SM will also ensure that the CRO understands complex protocol processes and procedures and may support CRA protocol-specific training.
Job Duties & Responsibilities
- Act as Alexion point of contact for the site: develop and maintain productive relationships
- Provide feedback to Internal and External Stakeholders as appropriate
- Proactively oversee startup processes to ensure expeditious startup of studies. Work with CRO to overcome roadblocks and issues that may delay site initiation and activation.
- As required, conduct sponsor oversight site visits (SOSVs) to assess site and CRO performance to:
- Assess the quality of site monitoring activities undertaken by CRO personnel. Escalate and support corrective actions as required.
- Evaluate clinical trial sites to ensure site procedures are performed in accordance with the study protocol, applicable study manuals, GCP, and local regulatory requirements
- Troubleshoot issues and implement alternative and innovative approaches to solve problems impacting clinical site delivery and/or quality
- Accountable for identifying site and CRA performance issues, quality events and other quality issues at patient and/or site level, escalating, and supporting implementation of CAPAs to address these
- Work both independently and collaboratively with cross-functional teams and country affiliates
- Maintain tools to document and track sponsor oversight activities and issues, as required
- Review reports (or output of CRO report review) from site qualification, initiation and monitoring visits as applicable
- Communicate important clinical site assessment information to the study team and CRO
- Partner with Alexion Clinical Operations and Research staff to become knowledgeable on protocol procedures and requirements
- Participate in Country Calls and meetings with the CRO and other internal meetings as applicable
- May assist or lead study-related training of CRO personnel, particularly CRAs, and study site team members
- Partner with Alexion CRO study team members to provide on-site support, answer site questions and develop custom solutions as needed
- Provide insight and facilitate best practice sharing to Alexion and CRO study teams, e.g. effective implementation of complex protocol processes identified at high-performing sites
- Support inspection readiness and site preparation activities in the event of a regulatory authority inspection in partnership with the Alexion Quality function. Interface with regulatory inspectors, as needed.
- Remain current with GCP and global regulatory requirements and have working knowledge of local/regional regulatory requirements for assigned regions
- Extensive site management and monitoring experience across a range of highly complex disease areas
- Demonstrated capability of effective monitoring and site oversight
- Solid knowledge of clinical development processes with strong emphasis on monitoring
- Ability to lead, troubleshoot and influence for quality and delivery
- A track record of ensuring GCP compliance and successful risk management of complex clinical studies is expected
- Proven experience in effectively communicating with site staff including and including KOLs and thought leaders
- Experience in all study phases and in rare medical conditions preferred
- Previous oversight and regulatory inspection experience preferred
- Comprehensive and current regulatory knowledge, including GCPs
- Experience conducting GCP or other training is a plus
- Demonstrates flexibility in schedule and willingness to travel frequently in assigned region (required travel may be as high as 70% during busy periods)
- Good organizational skills and ability to deal with competing priorities
- Effective communication skills (written, verbal and presentation)
- Creative thinker, curious and unafraid to ask questions
- Innovator, willing to initiate changes, introduce new ideas, and creatively problem solve
- Proficient with MS Office Suite (Excel, Word and PowerPoint).
- Bachelor's Degree or equivalent in one of the disciplines relatd to clinical practice/health care, life sciences or drug development is required. A clinical or advanced degree (RN, MPH, MS, MA, MBA, PharmD,) is preferred.
- 5+ years of relevant experience with 3+ years of direct monitoring experience gained with a CRO or pharmaceutical company working on multinational clinical studies; Lead CRA/management experience preferred