United BioSource Corporation.

Sr Manager - Clinical Research

Location
Blue Bell, US
Salary
Competitive
Posted
11 Jun 2021
Closes
11 Jul 2021
Ref
2896
Discipline
Clinical Research
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)


Job Title:

YLM99I – Senior Manager - Clinical Research

Brief Description:

Plan, organize and lead UBC project teams to deliver projects based on client needs on time, on budget, and within scope. Mentor, provide support and oversee Associate Project Managers and/or Project Managers.

Specific job duties:
  • Managing projects as assigned
  • Assist, as directed, specific project opportunities in Business Development RFP review and completion and bid defense preparation and delivery
  • Direct supervision of multiple Project Managers, including development of Project Managers in presentation and bid defense of proposals, proposal and implementation of action plans, and ensuring Project Manager has a clear understanding of clients needs once a project is awarded
  • Ensure performance of project deliverables according to contract terms and UBC quality expectations, including accurate reporting and interpretation of metrics
  • Plan, develop and maintain UBC sponsor specific policies, procedures, operational plans, SOPs, systems, forms, reports and vendor/sub-contactor relationships according to sponsor guidelines and standards
  • Lead projects with cross functional involvement and supervise all functional areas that support the project
  • Oversight of all project revenue and invoicing with strong understanding of project financial health
  • Work with UBC’s leadership and UBC Business Development to develop and grow UBC Sponsor relationship and business to maximum potential
  • Proactively serve as a resource and mentor to Project Managers and teams for problem resolution; facilitate the involvement of UBC senior management as necessary
  • Proactively identify areas of improvement, provide solutions and execute plan of action to address
  • Participate in client meetings, calls and project specific activities as appropriate to ensure Project Managers are meeting client’s needs in a systematic manner
  • Lead APM/PMs in sponsor/regulatory audits as required
  • May be asked to assist in protocol development and/or patient/subject consent form or REMS and REMS Supporting Documents as required
  • Other duties as assigned by management

Supervisory Responsibility:
  • Responsible for at least 1 direct report in addition to supervision of multiple Project Managers and projects as assigned
  • Serve as a resource and mentor to the APM/PM in the execution of their daily activities
  • Proactively assist the APM/PM in anticipating and seeking resolutions to potential and actual project issues
  • Motivate project team members by fostering teamwork
  • Maintain positive attitude
  • Ability to plan to the extent that you are ten steps ahead and know ‘what’s next’ not only for success but for challenges as well
  • Ability to identify and make optimal use of resources as well as when to request additional/different resources

Desired Skills and Qualifications:
  • Advanced Degree preferred, bachelor’s degree or equivalent experience required
  • Extensive project management experience at a CRO or proven leadership/management experience managing multiple projects and project teams (additional or other relevant management experience may be considered)
  • Strong knowledge of FDA/ICH regulatory guidelines
  • Working knowledge of functional components of clinical drug development (e.g. clinical, data management, statistics and regulatory/medical writing)
  • Mastery of project management skills with the ability to lead through change and independently lead multiple large projects simultaneously
  • Solid problem-solving and analytical skills with willingness and ability to detect process gaps, challenge assumptions, and drive change and improvement
  • Ability to work in a team environment under high pressure situations
  • Excellent interpersonal and written and communication skills
  • Proven ability to interpret and prioritize customer needs
  • Strong influencing and negotiation skills
  • Takes initiative and is results and detail oriented
  • Ability to build strong business relationships across various departments
  • Broad therapeutic experience a plus
  • 10% travel as required


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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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