Description
Clinical Operations Lead Associate DirectorZurich/Basel - Switzerland ( 12 Month Contract )
Position Summary
The Clinical Operations Lead, Senior Manager (COL-SM) oversees outsourced (or CRO) start up and monitoring activities to ensure the execution of study deliverables at the site and country level, adherence to good clinical practices (GCP) and relevant regulatory requirements, and consistency and quality of monitoring activities.
The COL-SM will be responsible for coordinating and driving start up activities across assigned countries and/or regions in partnership with the CRO, adhering to study timelines and milestones as well as identifying and communicating risks to the global study team.
The COL-SM will oversee the CRO monitoring study sites to ensure effective identification and problem solving of issues. Identified issues and mitigations will be communicated to both the study team and the CRO.
The COL-SM will ensure that the CRO CRAs understand complex protocol processes and procedures and may support CRA protocol-specific training.
Job Duties & Responsibilities
- 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.
- Support and drive in-country/regional study feasibility
- Develop close relationships with clinical site staff and Investigators as appropriate to ensure optimal Sponsor-site relationships
- Drive high quality through identification and management of issues at the country level, including understanding when decision making can occur at local level and when escalation to the global study team is required.
- Review visit reports (or output of CRO report review) from site qualification, initiation and monitoring visits as applicable
- As required, conduct sponsor oversight site visits (SOSVs) to assess site and CRO performance to:
- 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
- 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 CRO study team members to provide on-site support, answer site questions, and develop custom solutions as needed
- Effective implementation of complex protocol processes identified at high-performing sites
- Remain current with GCP and global regulatory requirements and have working knowledge of local/regional regulatory requirements for assigned regions
Qualifications
- Proven experience in the oversight and delivery of operational aspects of all stages of of clinical trial process
- 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).
Background and experience
- 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.
- 8+ 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
Michael Bailey International is acting as an Employment Business in relation to this vacancy.