Project Manager, Evidence - Remote (US)

Location: Morrisville, North Carolina, United States

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Requisition Number: 1501

Position Title: Project Manager, Evidence

External Description:

SUMMARY: The Project Manager, Evidence, is responsible for the overall coordination and management of observational research projects, comprising large, national, international, or global studies and/or complex studies to meet the needs of a variety of stakeholders across the entire healthcare value chain. From start-up through successful completion, the Project Manager is responsible for all operational study components: serving as the sponsor’s primary point of contact, managing the internal project team, ensuring milestones are achieved per the timelines, adhering to the budget, managing the study’s scope, employing a flexible approach customized to meet each study’s needs, ensuring the appropriate procedures and processes are followed, managing vendors, providing excellent and high-quality services, and updating internal tools in support of the project(s).

 

Real World Evidence (RWE) / non-interventional study experience at a CRO, biotech or pharma is required.

 

  • Oversees and directs all operational, financial, and technical aspects of assigned project(s); escalating key issues to Senior Management, as appropriate
  • Leads the internal project team, working with functional area leads across internal units, to identify, evaluate, and efficiently address fundamental project requirements and training needs
  • Communicates regularly with sponsor(s) and Senior Management regarding budget, time, and quality requirements associated with milestones and key deliverables
  • Ensures successful design, implementation, tracking and revision of project plans, monitoring the scope of services and being accountable for risk management, problem-solving, and contingency planning
  • Provides a high level of customer service and builds solid relationship with sponsor(s)
  • Utilizes internal tools (Sciforma, PPR, etc.) to monitor project scope and performance; maintains dialogue with Senior Management and internal team(s), as appropriate

 

RESPONSIBILITIES:

  • Lead cross-unit coordination, both internal and external, inclusive of vendors and sub-contractors
  • Strive to independently anticipate and solve complex sponsor issues in a timely and appropriate manner
  • Initiate improvements to enhance the efficiency and the quality of the work performed on assigned project(s)
  • Promote effective teamwork, motivating team members and encouraging them to take positive actions and be accountable; resolve conflict, when needed
  • Ensure appropriate communication on project-related matters with Senior Management
  • Understand study budgets and take appropriate steps to meet financial performance targets for assigned projects
  • Ensure that staff allocated to assigned projects are trained on the study protocol and adhere to professional standards, SOPs, and study-specific processes
  • Ensure that company, sponsor, and applicable regulatory policies and procedures are followed
  • Contribute to and/or oversee the development of study deliverables (reports, publications and presentations); ensure deliverables are produced according to WCT and sponsor expectations
  • Remain current with industry guidelines, regulatory requirements, technologies, etc. as it pertains to real world evidence and observational research
  • Support staff and liaise with functional line management to identify training or development needs; provide input into the performance appraisal process for team members
  • May work on multiple projects simultaneously
  • Participate in regularly occurring meetings with Senior Management to keep them apprised of the project’s status, successes, risks, and financial performance

 

 OTHER SKILLS AND ABILITIES:

  • Strong written, verbal, and presentation skills (English and local language)
  • Superior planning, organizational skills with attention to details
  • Strong leadership and interpersonal skills
  • Confident decision maker
  • Able to work with minimal supervision, in a team environment with an emphasis on collaboration and maintaining positive relationships with colleagues and sponsors
  • Knowledge of project management principles, application, and cross-functional management (time, quality, cost)
  • Able to delegate effectively and prioritize own and project team members’ workloads
  • Able to use diplomacy and tact with dealing with problems; able to negotiate and determine the appropriate course of action for resolution
  • Strong financial acumen: knowledge of budgeting, forecasting, and resource management
  • Solid understanding of clinical research principles and processes
  • Able to review, assimilate, and summarize complex medical information
  • Cross-cultural awareness and ability to adapt appropriately
  • Technologically proficient and responsible in remote work environment: able to use standard office equipment, software, and other business applications

 

REQUIREMENTS:

  • University/college degree (life science preferred) from an accredited college or university
  • Minimum of five (5) years relevant experience in clinical research environment; including demonstrated skills and competency in project management tasks 
  • In lieu of the above requirements, candidates with > three (3) years supervisory experience in a health care setting and four (4) years clinical research experience in the pharmaceutical or CRO industries will be considered and/or proven ability and demonstration of relevant experience and skills
  • Experience managing late phase, post-approval, observational research studies, and/or other complex clinical studies
  • Demonstrated skills and competency in clinical Project Management
  • Track record of success leading and developing project teams
  • Awareness of local and/or international regulatory requirements
  • Proven experience developing and managing budgets and resources; competent using project management software
  • Available for domestic and international travel, including overnight stays (valid passport)

#LI-HH1 #LI-Remote

City:

State: North Carolina

Employment Type: Regular

Community / Marketing Title: Project Manager, Evidence - Remote (US)

Company Profile:

We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.

Location_formattedLocationLong: Morrisville, North Carolina US

CountryEEOText_Description: Worldwide Clinical Trials is an equal opportunity employer, dedicated to a policy of non-discrimination in employment on any basis including age, sex, color, race, creed, national origin, religion, marital status, sexual orientation, political belief or disability.

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