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Manager Program / Project Management (Clinical Research) – Watertown, MA or Wilmington, DE preferred location - PS21308Location: Watertown, Massachusetts, United StatesNewRequisition #: PS21308Founded in 1996, and now an independently–operating subsidiary of Anthem, Inc., Healthcore/NERI provides care system, biopharmaceutical industry, academia, and the Federal Government with “real-world” data to improve the quality, safety, and affordability of healthcare. Healthcore’s projects range from retrospective to large scale, prospective studies in the areas of drug, vaccine , and medical devices safety surveillance, risk management, pharmacoepidemiology, health outcomes, pharmacoeconomics, and comparative effectiveness research.Recently acquired by HealthCore, Inc.,New England Research Institutes (NERI) was founded in 1986 and has grown to become a research organization with a global reputation for high-quality research, innovative thinking, and the use of state-of-the-science tools and techniques. NERI continues to be a leader in public health research, clinical trials management, epidemiology, and state of the art media and dissemination research.Manager Program / Project Management (Clinical Research) – Watertown, MA or Wilmington, DE preferred locationsThe Manager Program / Project Management (Clinical Research) is responsible for ensuring the overall success of multiple, cross-functional programs/projects through functional managers. Programs may include cultural change, regional planning, process improvement, change management, and quality initiatives. Position willsupervise staff members of the Clinical Research Operations group, meet regularly with direct reports and provide guidance and expertise.Primary duties may include, but are not limited to:
Supervise staff members of the Clinical Research Operations Group.
Develop Project Management Plan and oversee completion of project tasks and deliverables; escalate to Project Leadership as needed.
Finalize clinical trial documents and reports: create drafts, gather input from key stakeholders, perform final edits and seek required approvals.
Oversee completion of Site Management/Monitoring Plan and provide guidance to site management staff regarding site activation, regulatory document collection, data cleaning and monitoring.
Oversee completion of the Data Management plan and provide guidance to data management staff regarding DMS design and data cleaning.
Plans program/project scope and design.
Facilitates determination of required deliverables and validation of ROI.
Establishes process to continually monitor program progress.
Develops metrics and program/project reporting tools.
Analyzes variance to program/project plan.
Leads building of documentation to support business objectives and ensure consistency.
Responsible for championing local stakeholders and tactical decision-makers.
Hires, trains, coaches, counsels, and evaluates performance of direct reports.
This position will require experience with larger, more complex studies and the ability to creatively and proactively mitigate risks to study conduct.
May participate in proposal development and the submission of bids to clients and/or government entities as well as client meetings and bid defense meetings.
Qualifications:
Requires a BA/BS degree, 5-7 years of experience in project/program management, process reengineering, organizational design, and/or implementation; or any combination of education and experience, which would provide an equivalent background.
Clinical research experience required.
Experience managing clinical research projects, including real-world or late phase studiespreferably in a life sciences (biopharmaceutical) company or contract research organization, required.
High level work knowledge of GCP, ICH and FDQ regulations highly desired.
Effective communication and interpersonal skills required.
Ability to establish and maintain effective working relationships with coworkers, managers and clients required.
Excellent time management and organizational skills required.
Proven ability to manage projects and make independent decisions required.
Ability to travel maybe required.
Anthem, Inc. is ranked as one of America’s Most Admired Companies among health insurers by Fortune magazine and is a 2018 DiversityInc magazine Top 50 Company for Diversity. To learn more about our company and apply, please visit us at careers.antheminc.com. An Equal Opportunity Employer/Disability/Veteran.
