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Start up Lead

1 hour, 35 minutes ago
Turkey
Full-time
Senior
Project Manager
Project and Program Management
Apply Now
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
View All Jobs 88

Description

  • Manage the site start-up process by developing an activation readiness strategy and overseeing delivery.
  • Coordinate critical path planning for IRB/EC and CA/MoH strategy, ICF customization, risk mitigations, IMP release requirements, and contract execution.
  • Collaborate with stakeholders to gather input for milestone planning and align operational goals for timely site activation.
  • Participate in client meetings to set expectations for delivery, communication, risk mitigation, status reporting, and site start-up metrics.
  • Partner with Functional Leaders and Site Start Up Specialists to identify delivery risks and implement mitigation actions.
  • Ensure tracking systems and study metrics are accurate, complete, and maintained in real time at study, country, and site levels.
  • Coordinate translations for documents required for regulatory submissions.
  • Maintain communication with Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts teams on project status and deliverables.
  • Act as a subject matter expert on site-level critical path data points, including local IRB/EC timelines, site contracts, and budget negotiation requirements.
  • Support country- or site-level start-up activities when needed.
  • Develop country-specific start-up summaries and process flows that identify timelines, risks, and success factors.
  • Support and facilitate training sessions on country start-up processes and serve as a resource for staff questions.
  • Mentor staff on local study start-up regulations, submissions, internal procedures, and SSDL.
  • Contribute to proposal activities, including slide development and client presentations.
  • Perform other duties as assigned by management.

Requirements

  • Bachelor’s degree in life sciences or a related field, or Registered Nurse (RN), or equivalent combination of education, training, and experience.
  • Experience in start-up within a CRO or pharmaceutical/biotech environment.
  • 2+ years of experience in project milestone management, resource management, budget management, and team coordination.
  • Demonstrated leadership experience driving cross-functional activities.
  • Excellent communication and organizational skills.
  • Experience using computerized information systems, electronic spreadsheets, word processing, 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/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 a sense of urgency.
  • Excellent time management, prioritization, presentation, interpersonal, and computer skills.
  • Occasional travel may be required.

Benefits

  • Remote work designation (#LI-Remote).
  • Equal opportunity employer status.
  • Reasonable accommodation available for candidates with disabilities during the application process.

Interested in this position?

Apply directly on the company website

Apply Now

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