Start-Up Lead (R1040356) in Wayne, PA at IQVIA™

Date Posted: 9/16/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Wayne, PA
  • Experience:
    Not Specified
  • Date Posted:
    9/16/2018
  • Job ID:
    R1040356

Job Description

Summary of Essential Job Functions

  • Serve as the client’s primary point of contact for start-up projects that are using a single FSP solution
  • Lead internal project kick-off meetings for single solution engagements which will include a review of the Statement of Work (SoW) and the service delivery model that will be followed to execute the services
  • Develop the investigator grant budget for the per patient grant and related site pass-through costs
  • Work with the Start-Up Manager or Senior Start-Up Manager to develop site-specific Confidential Disclosure Agreements (CDAs), Clinical Trial Agreements (CTAs), or other related contractual documents (collectively, the “contractual documents”) based upon client approved templates
  • Negotiate contractual documents using the negotiation and escalation plan that has been established with the client
  • Track the delivery of FSP services against the SoW and ensure that agreed up project targets and/or milestones are being achieved
  • Lead client specific or departmental projects which may require oversight of other FSP Solutions staff to ensure that these projects are delivered within the established timelines
  • Prepare ongoing unit based forecasts for assigned projects and measure performance against those forecasts
  • Serve as an internal escalation point for project related issues and challenges
  • Identify those elements that trigger an out-of-scope activity (i.e. additional tasks requested, timeline shift, sites added to the study) and work with the Vice President of FSP Solutions to prepare a Change Order
  • Other duties as assigned

Competencies

  • Analytical Thinking: Tackle problems by using a logical, systematic, sequential approach
  • Attention to Detail: Ensure that all work is complete and accurate with a focus on quality
  • Building Collaborative Relationships: Develop, maintain, and strengthen partnerships with others inside or outside the organization who can provide information, assistance, and support, including client and vendor relationships
  • Decisiveness: Make informed decisions in a timely manner
  • Technical Expertise: The ability to demonstrate depth of knowledge and skill in a technical area
  • Influencing Others: Gain others’ support for ideas, proposals, projects, and solutions
  • Initiative: Identifying what needs to be done and doing it before being asked or before the situation requires it
  • Time management: The ability to handle multiple tasks and changing priorities to meet deadlines in a dynamic environment
  • Oral Communication: The ability to express oneself clearly in conversations and interactions with others
  • Written Communication: The ability to express oneself clearly and succinctly in a professional manner
  • Coaching: The ability to coach junior staff, imparting knowledge and empowering them to succeed

Supervisory Responsibilities

This position does not have responsibility for managing people.


Minimum Experience Requirements

  • B.A./B.S. preferably in a business or science/health care field, nursing degree, or equivalent degree
  • Three (3) years of prior experience in a client service role at a biotechnology or pharmaceutical company, CRO, or other organization supporting clinical research or healthcare activities
  • Prior experience leading project teams, ideally in a clinical trials start-up group
  • Clinical study start-up experience with an emphasis on site contractual documents.

Skill Requirements

  • Ability to motivate self and others when working under pressure to meet deadlines
  • Ability to think and act strategically
  • Proficient with Microsoft Office, specifically MS-Excel and MS-Word
  • Demonstrated ability to delegate effectively, co-ordinate a team to achieve results
  • Knowledge of the clinical trial process including GCP, ICH guidelines and relevant FDA/EC regulations/guidelines
  • Multi-language skills are a plus
  • Strong organizational, presentation, documentation, and interpersonal skills as well as a willingness to work in a team-oriented environment
  • Strong analytical and problem solving skills
  • Willingness to be flexible as the business requires


Job ID: R1040356