Study Start Up Lead

This is a fully remote position, open to applicants in Poland.

📋 Description

• Oversee the study start-up process from site activation, collaborating with the Project Manager and Clinical Trial Lead to ensure prompt site activations.

• Engage in Sponsor meetings concerning study start-up, including the endorsement of SSU Operational Targets & risk mitigation for delivery, while setting client expectations for delivery, communication, reporting, and metrics.

• Collaborate closely with both Functional Leads and SSU Team Members to proactively pinpoint issues related to study start-up.

• Ensure the maintenance and update of relevant systems to assess study start-up progress metrics in relation to targets and timelines (at project, country, and site levels).

• Provide operational oversight to SSU Associates on assigned projects.

• Responsible for all submissions and securing approvals from IRB/ECs (including CTIS Part 2 package).

• May also manage submissions to Regulatory Authorities in non-EU countries (e.g., UK, Georgia, South Africa, etc.).

• Coordinate feasibility efforts and collaborate with Clinical Team Leads on site identification.

• Identify the components required for the Site Essential Document (SED) packet, reach agreement with relevant internal staff, track document completion and uploads, and communicate the status of documents to all parties (e.g., Sponsor, Site Staff, Internal Staff); participate as the SED Reviewer when necessary.

• Coordinate and formulate the Start-Up approach for IRB/EC approval at designated regional levels, including country-level approval, while overseeing specific activities from SSU Team Members.

• Collaborate with Clinical Team Leads and clients to determine requirements for the Site Initiation Visit (SIV) and Site Activation.

• Oversee the development of the informed consent form (ICF), including review, negotiation, and approval with relevant internal and external parties.

• Assist in business development through proposal preparation, review, and bid defense efforts.

• Manage site budget development, including review, negotiation, and approval with relevant internal and external parties.

• Facilitate the site contract negotiation process.

• Create country/site-specific startup timelines and strategies while supervising startup activities within the country.

• Promote collaboration among cross-functional teams concerning startup activities.

⛳️ Requirements

• Minimum of 4 years of industry experience, with at least 2+ years in leading study start-up or equivalent roles.

• Proven ability to lead a team of individuals during the study start-up process.

• Familiarity with relevant international regulatory requirements and guidelines (i.e., ICH-GCP, and/or EU-Directives).

• In-depth knowledge of Regulatory and Central/Local ethics submission processes for the assigned countries.

• Strategic and innovative risk management and contingency planning skills.

• Strong written and verbal communication abilities to convey complex ideas to study personnel, internal teams, and sponsors.

• Excellent organizational and interpersonal skills.

• Strategic and tactical thinking capabilities.

• Client-focused and action-oriented work approach.

• Ability to work independently, prioritize tasks, and collaborate within a matrix team environment is essential.

• Positive demeanor and capability to interact with all staff levels to coordinate and execute study activities.

• Strong presentation skills.

• Global start-up experience is preferred.

• Proficient in computer and internet applications, including a working knowledge of MS Office, such as MS Outlook, Word, and Excel.

• Expected travel requirement is approximately 10% on average.

🏝️ Benefits

• Comprehensive benefits package including health, dental, and vision insurance.

• Opportunities for professional development and continued education.

• Flexible work arrangements and a supportive work environment.