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Position Summary:
MannKind Corporation is currently seeking a Clinical Trials Site Manager (CTSM) (Sr. Manager). This role is an integral part of the clinical operations team, responsible for supporting the sites conducting our clinical trials from study start-up to close out. The site manager will conduct on-site visits on a rotating cycle to ensure site support by helping to identify and resolve recruitment challenges. The CTSM will also be a direct Sponsor team member who will listen to the sites concerns related to challenges with CRA/CRO, challenges with the Sponsor, and/or the various vendors that will be supporting the conduct of the trials. The CTSM role will proactively identify, communicate and resolve site related issues identified before/during/after engagement visits. The CTSM will be an integral sponsor team member that will help the central study team oversight of recruitment, CRO/CRA activities and other external parties at the site level
Essential Duties and Job Functions:
- Act as sponsor point-of-contact for sites.
- Develop and maintain productive relationships with sites while conducting Sponsor Engagement Visits to discuss recruitment progress/challenges, study protocol challenges and assess fluidity of site activities undertaken by CRO personnel, site CRAs, and study related vendors.
- Support the CRA/CRO/Sponsor to resolve queries and site-specific issues that may be pending for extended periods of time, etc.
- Proactively escalates Site, Sponsor, CRO and/or CRA performance or quality issues at the participant and/or site level.
- Supports the Sponsor Central Study team in overseeing start-up processes to ensure expeditious start-up of studies within the geographical remit, as well as at the end of the study close out processes.
- Writes Site engagement reports after each onsite visit and follows open action items until closed.
- May be asked to support at a site level study specific protocol training to CRO and CRAs and addresses/escalates protocol-related training gaps that may be identified during site discussions.
- Provides feedback to internal and external stakeholders, as needed.
- Supports sites through the certification procedures including Investigator Meeting and Site Initiation Meeting planning, if necessary.
- Tracks and reports progress of site recruitment plans against their site enrollment targets, in addition to supporting the site in identifying and resolve challenges/barriers,
Knowledge, Experience and Skills:
- Requires a four-year degree in biological sciences or a related field and 8+ years of relevant experience as a Clinical Trial Site Manager or similar role
- 2+ years of direct monitoring experience gained with a Contract Research Organization (CRO) or pharmaceutical company working on multinational clinical studies would be preferred, but not required
- Extensive site management experience across a range of highly complex disease areas; rare disease experience preferred
- Demonstrated flexibility in schedule and willingness to travel frequently in assigned region (required travel may be as high as 60-75%)
- Excellent verbal and written communication skills and interpersonal skills to build/maintain strong relationships with clinical sites, key opinion leaders and thought leaders
- Demonstrated ability of effective site oversight and engagement
- Demonstrated organizational skills and ability to deal with competing priorities
- Demonstrated ability to lead, troubleshoot and influence for quality and delivery of solutions
- Creative thinker, curious and unafraid to ask questions
- Innovator, willing to initiate changes, introduce new ideas, and creatively problem solve
- Proficient in Microsoft Office products (Word, Excel, PowerPoint, etc.), including SharePoint and other collaboration tools
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Mannkind Corporation
Feb 13, 2025 