Associate Start up Lead

1 hour, 35 minutes ago
Full-time
Junior
Project and Program Management
Precision Medicine Group

Precision Medicine Group

Precision Medicine Group specializes in precision medicine, utilizing targeted expertise and data insights to accelerate drug development and enhance the commercialization of next-generation medical products for the pharmaceutical and life sciences ind...

Pharmaceuticals
251-1K
Founded 2012

Description

  • Manage the site start-up process through an activation readiness strategy that supports oversight of delivery.
  • Develop and present critical path plans, including IRB/EC strategy, CA/MoH strategy where applicable, ICF customization, risk mitigations, IMP release requirements, and contract execution.
  • Collaborate with stakeholders to secure input for milestone planning and align operational goals to meet activation timelines.
  • 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 mitigations.
  • Oversee tracking systems and data quality to ensure accurate, real-time progress monitoring 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 for local site-level critical path and IMP release data points, including IRB/EC timelines, reviews, contracts, and budget negotiation requirements.
  • Support country- or site-level start-up activities when needed, and help develop country start-up summaries, process flows, and training sessions.

Requirements

  • Bachelor's degree in life sciences or a related field, or RN, or equivalent combination of education, training, and experience.
  • 3+ years of experience in start-up activities, ideally as a Start-Up Lead or Project Manager in 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 software, and email.
  • Experience using milestone tracking tools or systems.
  • Fluency in English; for non-English speaking countries, fluency in the local language of the country where the role is based.
  • Preferred: advanced degree in life sciences or a related field.
  • Knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements.
  • Ability to work independently in a fast-paced environment with strong attention to detail, time management, and prioritization skills.
  • Occasional travel may be required.

Benefits

  • Fully remote work available from Serbia, Romania, Hungary, Slovakia, or Poland.
  • 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

Similar Roles

Senior Clinical Research Associate

Precision For Medicine 1K-5K Pharmaceuticals

Precision for Medicine is hiring a Senior Clinical Research Associate in Taiwan to manage complex oncology and rare disease clinical trials from site start-up through monitoring, data quality, and site oversight.

20 minutes ago

[HELLOCONNECT] Client Solutions & Onboarding Manager

HelloFresh 10K-50K Hotels, Restaurants & Leisure

HelloConnect is hiring a client-facing operations and deal management professional to bridge Sales and Operations and own the client journey from qualified lead through pricing, contracting, and operational launch.

JIRA
20 minutes ago

Onboarding Project Manager

Block 10K-50K Capital Markets

Square, part of Block, is hiring an Onboarding Project Manager to lead technical onboarding and activation for its largest and most complex sellers, shaping enterprise deployments from pre-sale discovery through implementation.

REST API
35 minutes ago

Project Manager - Industrial

Olsson 1K-5K Construction & Engineering

Olsson is hiring an Engineering Project Manager to lead complex industrial facilities engineering and design projects from scope through completion.

35 minutes ago

You're on a roll! Sign up now to keep applying.

Sign Up

Already have an account? Log in

Used by 14,729+ remote workers