What are the responsibilities and job description for the Sr. Manager, Clinical Research, Site Manager position at Mannkind Corporation?

Position: Sr. Manager, Clinical Research, Site Manager

Location:

Remote

Job Id: 111130

# of Openings: 1

At MannKind our employees are our number one asset, and we continue to be a tight-knit community where each of us has a critical role in our success. Committed to diversity, at MannKind we depend on a rich blend of ideas, backgrounds, and working styles in our quest to change the world for the better.

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.

Pay Range: $124,000 - $186,000 per year

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Mannkind Corporation is proud to be an Equal Employment Opportunity employer. We provide equal employment opportunity (EEO) to all persons regardless of race, creed, color, religion, national origin, ancestry, gender (including pregnancy, breastfeeding or medical condition related to pregnancy or breastfeeding), age, physical or intellectual disability, sexual orientation, gender identity, gender expression, gender stereotyping, marital status, military or veteran status, citizenship, genetic characteristic or information, or any other characteristic protected by applicable federal, state, or local law.

Salary : $124,000 - $186,000

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