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Product Manager (Clinical Trials) job

PRA Health SciencesBlue Bell, PA
PRA Health Sciences jobs

Company

Salary

Skills

Company Description

The story of PRA Health Sciences would naturally talk about how we’ve become one of the world’s largest CROs. It would talk about our innovation and growth and would speak to our operational efficiencies and transparency. It would highlight our expertise and customization. And it would touch on the incredible differences we’ve made, over our more than 30 years, in helping to bring to market everything from niche treatments and therapies to blockbuster drugs. More than anything else, our story would be about people. Not only our over 15,000 employees operating in more than 85 countries, though they’d certainly be a big part of it, but also the people that inspire them. The heroes of any PRA Health Sciences story are the clients we serve and the people whose lives we help improve, all over the world. And our story has only just begun.

Job Description

Overview

Overview:

A Product Manager is responsible for a product or service area throughout the product lifecycle including vision, requirements, deployment, and optimization. A given PRA product area typically includes the information systems and processes necessary to deliver the product or service to internal and/or external stakeholders. Product Managers work across functional departments to deliver products, system enhancements, and process change that increases efficiency, profitability, and client satisfaction. Product Managers typically report to a Director or Vice President. 

Responsibilities:

  • Facilitates the definition and prioritization of requirements, systems enhancements, and process improvement from user communities by leading systems management teams and regularly communicating with key stakeholders for the product area.
  • Develops project proposals, presents proposals to the strategic technology office, determines the return on investment, and if approved, develops project charters.
  • Partners with project managers to ensure that requirements are fulfilled, and the launch of the product or enhancement is successful.
  • Participates in and develops stakeholder communications, user training, and product demonstrations.
  • Develops product materials and collateral to increase internal and external adoption of systems and processes.      
  • Accountable for the management of product schedules, budgets, and achievement of objectives.
  • May manage external vendors and/or contractors to deliver products.    

Qualifications:

  • An undergraduate degree in life sciences, business, or information technology from an accredited institution or international equivalent degree is required.
  • Strong project management experience is required, with an emphasis on driving projects forward. 
  • Prior CRO experience is ideal. Clinical trials experience is required. 
  • Experience with IXRS is highly desired. 
  • Experience conducting a system upgrade is ideal.
  • Experience with ePRO/eCOA is desired.
  • Issue management experience with vendors is important. Must be able to effectively escalate issues and problem-solve.
  • The ideal candidate will have experience with patches, upgrades, and compliance with 21 CFR Part 11.
  • Experience with MHRA and other regulatory agencies is desired. 
  • At least 3 years of demonstrated experience delivering process and system improvement in one or more of the following disciplines and/or functional areas:
  • Drug Development, Early Development thru Post‐Marketing (phases I‐IV)
  • Clinical trial/project development
  • Data management
  • Project management
  • Safety Pharmacovigilance
  • Financial management tools
  • Resource management
  • Regulatory compliance (ICH‐GCP)
  • Quality Management (ISO, Six Sigma, etc.)
  • Technology management 
  • Domestic travel of 5 – 10% is anticipated for governance meetings with vendors a few times per year and conferences.
  • To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.

PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.

Estimated annual salary
$115,851
average
Minimum
$67,268
Maximum
$128,664

TASKS

  • Confer with scientists, engineers, regulators, or others to plan or review projects or to provide technical assistance.
  • Develop client relationships and communicate with clients to explain proposals, present research findings, establish specifications, or discuss project status.
  • Plan or direct research, development, or production activities.
  • Review project activities and prepare and review research, testing, or operational reports.

SKILLS

  • Reading ComprehensionUnderstanding written sentences and paragraphs in work related documents.
  • Active ListeningGiving full attention to what other people are saying, taking time to understand the points being made, asking questions as appropriate, and not interrupting at inappropriate times.
  • WritingCommunicating effectively in writing as appropriate for the needs of the audience.
  • SpeakingTalking to others to convey information effectively.

KNOWLEDGE

  • Administration and ManagementKnowledge of business and management principles involved in strategic planning, resource allocation, human resources modeling, leadership technique, production methods, and coordination of people and resources.
  • Customer and Personal ServiceKnowledge of principles and processes for providing customer and personal services. This includes customer needs assessment, meeting quality standards for services, and evaluation of customer satisfaction.
  • Computers and ElectronicsKnowledge of circuit boards, processors, chips, electronic equipment, and computer hardware and software, including applications and programming.
  • MathematicsKnowledge of arithmetic, algebra, geometry, calculus, statistics, and their applications.

PRA Health Sciences

Type

Company - Public

Size

10000+

Revenue

$100M to $500M

Location

Raleigh, NC,

Industry

Pharmaceutical/Bio-tech

Founded

1976

CEO

Colin Shannon

Job Filters

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Closed Job Filters

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