Late Phase Research Project Manager Senior-PS6422Anthem, Inc. - Watertown, MA
Late Phase Research Project Manager Senior-PS6422
Late Phase Research Project Manager Senior-PS6422
Wilmington, Delaware, United States
Reporting & Data Analysis
7 hours ago
LATE PHASE PROJECT MANAGER, SENIOR
HealthCore, Inc., a health services research firm headquartered in Wilmington, DE is seeking a Late Phase Project Manager, Senior to join our dynamic company. Founded in 1996, and now an independently-operating subsidiary of Anthem, Inc., HealthCore provides the health care system, biopharmaceutical industry, academia, as well as federal and state governments with real-world data to improve the quality, safety, and affordability of healthcare. HealthCoreâ€™s projects range from retrospective to large-scale, prospective studies in the areas of drug, vaccine, and medical device safety surveillance, risk management, pharmacoepidemiology, health outcomes, pharmacoeconomics, and comparative effectiveness research.
currently seeking an experienced Late Phase Project Manager, Senior to join our team in our Watertown, MA or Wilmington, DE location.
Remote may also be considered.The primary role of the Late Phase Project Manager is to ensure project deliverables are in line with project's scope of work, timelines and quality metrics. This role is also responsible for the overall direction, coordination, implementation, and completion of projects ensuring consistency with company strategy, commitments and goals. The ideal candidate will have experience managing late phase studies with an appreciation of how real world evidence functions such as HEOR, Safety and Epidemiology, in addition to site management and data management contribute to the success of such studies. A thorough understanding of GCP and GEP/GPP guidelines is also required.
Implementing prospective site-based late phase observational research studies under the direction of senior staff:
Oversees proposal development and contributes to the design of research studies to fulfill study objectives
Assists in the preparation for and attends bid defense meetings
Manages all study-related activities from study start to close-out in order to meet defined study timelines and objectives;
Develops and implements proactive risk mitigation strategies.
Coordinates the preparation of study documents such as Informed Consent forms, project plans, and clinical trial agreement templates.
Ensures compliance with regulatory requirements (as applicable), Standard Operating Procedures, and confirms that all HealthCore and Sponsor legal and business requirements are met.
Coordinates the development of site tools and checklists as well as site tracking templates (e.g., Screening and Enrollment Logs, Material Tracking forms).
Ensures the development and maintenance of project-specific tracking systems(CTMS) to enable proper study management and monitoring activities, as required.
Collaborates with other project team members to produce high quality reports, presentations, proposals and other milestone deliverables in a timely manner.
Participates in external vendor selection process.
Conducts regular study team meetings including creating agendas and providing meeting minutes.
Develops study budgets and monitors study payments; leads financial metric review of studies.
Participates in identifying resourcing needs for assigned projects.
Mentors and directs junior staff as appropriate.
This position requires a bachelorâ€™s degree and 13 or more years experience including 9 years of experience in clinical research with at least 4-5 years in project management. Excellent communication, writing and presentation skills are essential. The ability to work effectively on cross functional teams and manage multiple and varied tasks is important.
Working at HealthCore
In addition to a dynamic work environment, HealthCore offers a competitive salary outstanding benefits program, including 401(k); health, dental, and vision insurance; discounted fitness club membership; life, AD&D, short and long-term disability insurance; tuition assistance, employee stock purchase program; and free parking.
HealthCore is headquartered in Wilmington, DE, midway between New York City and Washington, DC, with offices in Alexandria, VA; Andover, and Watertown, MA; and Atlanta, GA. As an independently operating subsidiary of Anthem, HealthCore offers the resources of the nationâ€™s leading health benefits company in a small company environment. To learn more about us or apply for a position, please visit ~~~ at ~~~/ .
8 days 1 hour ago
applyLate Phase Research Project Manager Senior-PS6422 Anthem, Inc. - Watertown, MA, United States
The company was formed when WellPoint Health Networks Inc. and Anthem, Inc. merged in 2004 to become the nation's leading health benefits company. The parent company originally assumed the WellPoint, Inc. name at the time of the merger. In December 2014, WellPoint, Inc. changed its corporate name to Anthem, Inc. The Anthem brand is built on a foundation of trust – it’s the name consumers are most familiar with as a trusted health care partner through our affiliated health plans. Anthem, Inc. is one of the largest health benefits companies in the United States. Through its affiliated health plans, Anthem companies deliver a number of leading health benefit solutions through a broad portfolio of integrated health care plans and related services, along with a wide range of specialty products such as life and disability insurance benefits, dental, vision, behavioral health benefit services, as well as long term care insurance and flexible spending accounts. Headquartered in Indianapolis, Indiana, Anthem, Inc. is an independent licensee of the Blue Cross and Blue Shield Association serving members in California, Colorado, Connecticut, Georgia, Indiana, Kentucky, Maine, Missouri, Nevada, New Hampshire, New York, Ohio, Virginia and Wisconsin; and specialty plan members in other states.
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