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Associate Start up Lead

1 hour, 47 minutes ago
Serbia, Slovakia, Hungary, Poland, Romania
Full-time
Mid Level
Program 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 132

Description

  • Manage the site start-up process through activation readiness strategy and oversight of delivery.
  • Coordinate critical path planning, including IRB/EC strategy, CA/MoH strategy where assigned, 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 plans.
  • Maintain accurate, real-time tracking systems and reporting to monitor progress against study, country, and site targets.
  • Coordinate translations for documents required for submissions.
  • Maintain communication with Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts teams on status and deliverables.
  • Act as subject matter expert on site-level critical path items, including ethics timelines, site contracts, budget negotiations, and other start-up requirements.
  • Support country or site-level start-up activities when needed, including development of country start-up summaries, process flows, and training sessions.
  • Mentor staff on local study start-up regulations, submissions, internal procedures, and SSDL.
  • Support proposal activities, including slide development and client presentations, as required.

Requirements

  • Bachelor's degree in life sciences or a related field, Registered Nurse (RN), or equivalent combination of education, training, and experience.
  • 3+ years of experience in start-up, ideally in a Site 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 team coordination.
  • 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, and email.
  • Experience using milestone tracking tools/systems.
  • Fluency in English and, for non-English-speaking countries, the local language of the country where the position is based.
  • Preferred: advanced degree in life sciences or a related field.
  • Knowledge of Good Clinical Practice (GCP), ICH Guidelines, and other applicable regulatory requirements.
  • Ability to work independently in a fast-paced environment with strong attention to detail, accuracy, time management, and prioritization.
  • Excellent computer skills and strong written and spoken communication, presentation, and interpersonal skills.
  • Occasional travel may be required.

Benefits

  • Fully remote work from Serbia, Romania, Hungary, Slovakia, or Poland.
  • Discretionary annual bonus.
  • Private medical insurance.
  • MultiSport Card.
  • Life insurance.
  • Pension plan.
  • Home working allowance.
  • Vacation leave.
  • Reasonable estimate of the current compensation range for Poland: 142,900 PLN - 214,300 PLN gross per annum.

Interested in this position?

Apply directly on the company website

Apply Now

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