Associate Start up Lead

1 hour, 40 minutes ago
Full-time
Senior
Project and Program Management
Precision For Medicine

Precision For Medicine

Precision for Medicine is a specialized scientific services company that helps pharmaceutical and life sciences clients innovate, develop, and commercialize next-generation medical products. With a diverse team of experts, they offer comprehensive serv...

Pharmaceuticals
1K-5K
Founded 2012
$225M raised

Description

  • Manage the site start-up process by developing activation readiness strategies and overseeing delivery.
  • Coordinate critical path planning, including IRB/EC strategy, CA/MoH strategy, ICF customization, risk mitigation, IMP release requirements, and contract execution.
  • Collaborate with stakeholders to gather input for milestone planning and align operational goals to support timely site activation.
  • Participate in client meetings to define expectations for delivery, communication, risk mitigation, status reporting, and site start-up metrics.
  • Partner with Functional Leaders and Site Start-up Specialists to identify risks and implement mitigations that protect timelines.
  • Maintain accurate tracking systems and real-time data to monitor progress against targets at study, country, and site levels.
  • Coordinate translations for documents required for submissions.
  • Communicate project status and deliverables with Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts teams.
  • Act as a subject matter expert on site-level critical path and IMP release data points, including IRB/EC timelines, reviews, site contracts, and budget negotiations.
  • Support country- and site-level start-up activities when needed, including training development, mentoring, and client proposal support.

Requirements

  • Bachelor's degree in life sciences or a related field, or Registered Nurse (RN), or equivalent combination of education, training, and experience.
  • 3+ years of experience in start-up, ideally in a Start-Up Lead or Project Manager role within a CRO or pharmaceutical/biotech environment.
  • 1+ year of experience in project milestone management, resource management, budget management, and coordinating team activities.
  • 1+ year of experience presenting to clients.
  • Demonstrated leadership experience driving cross-functional activities.
  • Excellent communication and organizational skills.
  • Experience using computerized information systems, electronic spreadsheets, word processing software, and email.
  • Fluency in English and, for non-English-speaking countries, the local language of the country where the position is based.
  • Experience using milestone tracking tools or systems.
  • Advanced degree in life sciences or a related field (preferred).
  • Knowledge of Good Clinical Practice (GCP), ICH Guidelines, and other applicable regulatory requirements.
  • Ability to work independently in a fast-paced environment with strong time management and prioritization skills.
  • Excellent computer skills, including attention to detail and accuracy.
  • Ability to interact effectively with project teams and communicate, present, influence, and persuade in English and the local language.
  • Occasional travel may be required.

Benefits

  • Fully remote work option from Serbia, Romania, Hungary, Slovakia, or Poland.
  • Equal opportunity employer policies.
  • Reasonable accommodation support for applicants with disabilities.
  • Privacy policy and CA privacy notice for applicant data protection.

Interested in this position?

Apply directly on the company website

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