Senior Regional Site Manager
We are currently searching for a skilled professional to join a well-known client’s Ophthalmology, Dermatology, and Device team as a Senior Regional Site Manager (Senior RSM) in the Midwest region. The Senior RSM will have a direct impact on not just the organization but the larger clinical industry making this an amazing career opportunity. The Senior Regional Site Manager (Senior RSM) is responsible for overseeing the conduct of clinical trials at investigative sites to ensure the quality and integrity of data and to ensure that the rights and welfare of research subjects are protected.
The Senior Regional Site Manager is a regional, home-based position.
- Conduct the following monitoring visits according to applicable SOPs, Working Documents, GCP/ICH guidelines, Protocol Specific Monitoring Plans, and departmental timelines
- Partnering with sites to ensure recruitment goals are met
- Assisting sites with operational needs (e.g. vendor activities, site payment)
- Primary contact for all issues that arise with sites
- Submit monitoring visit reports (MVRs) for all monitoring visits conducted
- Send follow-up letter to Principal Investigator summarizing visit conduct and all action items
- Contact the Regional Operations Manager (ROM) and Project Lead (PL) regarding significant site conduct issues
- Complete GXP Compliance audit responses in conjunction with ROM and PL
- Submission of MVRs in CTMS
- Submission of MVRs to the TMF
- Freezing of all electronic case report forms
- Retrieval of all paper case report forms (if applicable)
- Maintenance of calendar
- Submission of weekly time and expense reports
- Attend and participate in Annual Global Site Management Operations meeting, Regional Global Site Management Operations meetings, Investigator Meetings, Regional Site Manager teleconferences, Regular regional teleconferences
- Review and provide input to protocols and Case Report Forms
- Act as primary author for Protocol-Specific Monitoring Plan
- Present monitoring plan and monitoring expectations at the Investigators meeting
- Maintain SharePoint and/or Global Site Management Operations portal with study-specific information
- Present at regional and annual meetings for Global Site Management Operations
- Present components of Global Site Management Operations Orientation to newly hired Global Site Management Operations personnel
- Assist in development and maintenance of the Global Site Management Operations Orientation program
- Participate in regular meetings between Company and the CRO Conduct Monitoring Oversight Visits to clinical research sites
- Review and provide input to protocols, Case Report Forms, and monitoring plans
- Review Monitoring Visit Reports and provide feedback
- At least five years' recent experience in monitoring including Phase 1 experience
- Experience working in more than one therapeutic area
- Familiar with Electronic Data Capture preferred
- Experience with Risk Based Monitoring preferred
- Allied Health Professions degree (PA, RN, RPh), relevant clinical experience or four-year life science degree
- To be a best-fit your strengths must include
- Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.
- Organized. You’re an efficient time-manager and can handle the pressure of meeting multiple strict deadlines.
- Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure.
- Problem-Solvers. As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
- Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
- Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.
About Advanced Clinical
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.
Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.