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Manager, Site Management

MedAvante-ProPhase, a subsidiary of WIRB-Copernicus Group was founded in 2002 with the goal of helping to bring better drug therapies to market through smarter, faster clinical trials. With this goal in mind, MedAvante set out to solve one of Pharma's most intractable problems: the bias and variability that cause failed or inconclusive trials for Central Nervous System (CNS) therapies. A few years later, MedAvante experts pioneered Central Ratings and introduced the concept of Central Review utilizing their groundbreaking Virgil eSource solution. The Manager, Site Management is responsible for providing leadership and oversight to Site Management staff.  They ensure an effective partnership with investigative research sites and sponsor representatives.  The Manager Site Management ensures that the team is responsive, accountable and issues are responded to in a timely manner and resolved to an acceptable point.  The role will collaborate with internal departments to ensure that services are executed as per the study specific plans.  Responsibilities Lead and oversee a Global Site Management team. Manages site management activities between Project Management and the investigative research sites.  Ensure the set-up, training, and follow-up on operational questions, basic technical troubleshooting, data entry management and patient safety issues are addressed appropriately. Serves as a subject matter expert on the company's systems to support MedAvante clinicians, investigative sites and project activities. Interface with internal departments to evaluate project resources, needs, processes and timelines Ensure procedures are implemented and followed appropriately by the Site Management team. Review site data, including creating metrics that ensures project progression, as per contract.  Identify and streamline internal department processes. Monitor study-specific trial management tools/systems, ensuring appropriate use to trial management tools/systems and taking appropriate corrective action when needed. Attend investigator meetings, KOMs, project team meetings and teleconferences, as needed, representing site management team. When required, work with Business Development for project feasibility, RFP's and RFI's. Provides supervision and guidance to staff, as well as train and mentor team members.  Education / Qualifications: Bachelor's degree required, or certification in a related allied health profession from an appropriately accredited institution and extensive clinical trial experience.  (e.g., nursing certification, medical or laboratory technology) A minimum of 5 years working in a clinical services environment with direct site/sponsor contact. Experience working with psychiatric (e.g. depressions, anxiety) and/or neurocognition (e.g. Alzheimer's disease) indications required. Minimum 3 years' experience managing a team in a clinical services or clinical trials environment. Experience working in a matrix environment preferred Experience working with technical solutions for Clinical Trials preferred. Strong understanding of GCP. Strong Knowledge of IRB regulations and submissions (informed consent, etc). Experience / Skills Experience leveraging CRM tools (Salesforce, etc.) for case management, KPI reporting, and analysis for service delivery improvements. Ability to function effectively in a fast-paced environment and manage multiple projects and team members simultaneously. Must be able to exercise sound judgment in evaluating situations and making decisions, be flexible, work with interruptions, work in stressful situations, and shift priorities of work as required. Demonstrate leadership skills and ability to manage, motivate, and integrate a team. Ability to document and optimize relevant business processes. Strong customer service skills. Able to work flexible hours to provide support on a global basis. Strong problem solving/decision making skills. Ability to delegate project tasks and responsibilities. Advanced skill set in MS Office, specifically Word, Excel, Access and PowerPoint as well as Adobe, Visio and Microsoft OneNote and the ability to produce detailed reports and presentations using these tools, as needed. SUPERVISORY RESPONSIBILITIES: The position may require the individual to be responsible for the management, direction, coordination, performance, and evaluation of an assigned team and staff. Responsibilities may include training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems. TRAVEL REQUIREMENTS: Domestic and international travel, approximately 10% of the time, including overnight stays as necessary, consistent with project needs and office location.   WCG is proud to be an equal opportunity employer - Qualified applicants will receive consideration for employment without regard to race, color, national origin, religion, sex, sexual orientation, gender identity, age, marital status, disability, veteran status or any other status protected by law.
Salary Range: NA
Minimum Qualification
5 - 7 years

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