Start-Up Lead

Wayne, PA

Job Summary

The Start-Up Lead is responsible for providing the suite of FSP solutions to DrugDev clients. They will participate on a project team to deliver FSP solutions (site feasibility, patient feasibility, CTA negotiations, essential site document collection) on time, within budget, and in accordance with applicable financial, contractual, and pharmaceutical R&D industry standards and regulations.

Summary of Essential Job Functions

  • Serve as the client’s primary point of contact for global 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
  • Collect the essential site regulatory documents (i.e. FDA 1572, Investigator CVs, Financial Disclosures, IRB approvals, Informed Consent, credential checks, lab reference ranges, protocol signatures, Investigator Brochure, etc.), and participate in the 2-level quality review process
  • Oversee the delivery of Site Identification and/or Site Feasibility services on trials that utilize these services
  • 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


  • Analytical Thinking: Tackle problems by using a logical, systematic, sequential approach
  • Attention to Communication: The ability to ensure that information is passed on to others who should be kept informed
  • Building Collaborative Relationships: Develop, maintain, and strengthen partnerships with others inside or outside the organization who can provide information, assistance, and support
  • Decisiveness: Make difficult 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
  • Oral Communication: The ability to express oneself clearly in conversations and interactions with others
  • Thoroughness: Ensuring that one’s own and others’ work and information are complete and accurate
  • Written Communication: The ability to express oneself clearly in business writing

Supervisory Responsibilities

This position does not have responsibility for managing people.

Minimum Experience Requirements

  • 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
  • Study start-up experience in a clinical or regulatory operations capacity

Skill Requirements

  • Ability to handle multiple tasks to meet deadlines in a dynamic environment
  • 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
  • Good communication skills, both written and oral
  • 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

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Location: Wayne PA