United BioSource Corporation.

Sr Clinical Project Research Mgr

Expiring today

Location
Blue Bell, US
Salary
Competitive
Posted
09 Apr 2021
Closes
09 May 2021
Ref
2835
Discipline
Clinical Research
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)


Job Title:

Senior Project Manager

Brief Description:
  • Accurate reporting and interpretation of project metrics
  • Proposal and implementation of action plans
  • Satisfactory delivery of contracted services and achievement of contracted milestones for assigned projects
  • Financial integrity of assigned projects
  • Supervision of assigned project staff

Requirements:
  • College graduate
  • At least 5 years of clinical trial experience
  • Very good supervisory skills
  • Very good interpersonal skills
  • 10% travel

Supervisory Responsibilities:
  • Supervise project management staff in execution of assigned studies
  • Prepare PMs to make presentations to clients in defense of proposals
  • Ensure that the PM understands the client needs once a project is awarded
  • Serve as a resource and mentor to the Project Manager in the execution of their daily activities
  • Proactively assist the PM in anticipating and seeking resolutions to potential and actual project issues

Specific Job Duties:
  • Serve as the primary contact with the sponsor for all study related items, with oversight of all aspects of trial conduct, from study start-up through close-out in accordance with company and project specific SOPs, guidelines, budgets, timelines and contracts
  • Assist in the development and design of protocols, CRFs, regulatory documents, study master file, and other study related deliverables
  • Ensure operational plans are developed consistent with program needs, including but not limited to, the development of communication plans, monitoring plans, project plans, training plan, study timelines and clinical management plans; monitor project progress as compared to established plans and ensure compliance with plans
  • Facilitate and plan investigator meetings; recruit qualified investigators and assist in budget negotiations
  • Supervise monitors to ensure site visits occur as scheduled and trip reports are accurate and timely; reports to the Sponsor on study progress
  • Supervise other staff assigned to programs, including clinical site specialists (CSS) and regulatory associates (RA)
  • Ensure project training occurs
  • Serve as a resource to team members for all inquiries and issue resolution for site management, contract budget and remediation, and regulatory document preparation
  • Lead internal client teleconferences and/or meetings and present study information at client meetings, bid defenses and UBC monthly project review meetings
  • Assist in preparation of client proposals in response to RFPs
  • Ensure project budget is tracked against contract milestones
  • Duties described for Project Manager and other duties as assigned by management


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ABOUT UBC

United BioSource Corporation (UBC) is a leading provider of pharmaceutical support services, partnering with life science companies to make medicine and medical products safer and more accessible. Our services support the full lifecycle of medicine and medical products, including development, commercialization, and long-term value and safety.

While UBC offers employment within Patient Support, Nursing, Pharmacy and Corporate, two main focus areas for the company are Clinical Development & Research and Safety & Risk Management. Members of the Clinical Development and Research teams help evaluate study protocol, target study population, recruit physicians and patients, and collect, clean, validate and report data. As a result, sponsors are able to submit findings to regulatory authorities or make a no-go decision in a timely and clear-cut manner. Additionally, our Safety and Risk Management teams develop, deliver, and report evidence to reinforce safe and appropriate product use.

Through our Patient Access services, we help patients begin therapy quickly and remain on therapy, building strong relationships with patients to ensure optimal care.
You can find out more by visiting

www.ubc.com

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