Study Start-Up Associate – Contractor

🔥 14 hours ago

🇨🇦 Canada – Remote

⏳ Contract/Temporary

🟢 Junior

🟡 Mid-level

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Allucent

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

Allucent is a leading partner for small and mid-sized biotech companies, offering innovative regulatory and clinical development solutions. With over 30 years of experience, Allucent specializes in therapeutic expertise, clinical pharmacology, regulatory strategy, drug safety, and the pharmacovigilance processes needed to bring new therapies to market. Their comprehensive services address challenges from early-phase drug discovery through clinical trials and post-marketing surveillance, supporting various therapeutic areas such as oncology, infectious disease, neurology, autoimmune diseases, and rare diseases. Allucent's commitment to fostering breakthrough science helps biotech companies navigate the complexities of drug development efficiently and effectively.

📋 Description

• Track relevant information, data, progress, and milestones in CTMS and/or other tracking tools for assigned start-up activities • Ensure planned site start-up milestone dates are accurate and up to date in CTMS • File documents in the (e)TMF for which they are the document owner • Assist other Study Start-Up team members with filing documents in the (e)TMF • Complete the handover of the site to the CRA at the time of the SIV • Assist the sponsor and sites in preparing, compiling, submitting, and maintaining ethics requirements and documentation required by the IEC/IRB • Provide and review relevant documents in compliance with ethical requirements and local legislation • Support interactions with the IEC/IRB • Prepare, compile, and submit responses to IEC/IRB questions • Adapt the Master ICF to country- and site-specific requirements • Prepare site-specific Essential Records Packages and send them to sites • Collect and conduct an initial review of Essential Records • Provide collected documents to the Global Essential Document Reviewer for independent review • Follow up with sites on document discrepancies through resolution • May support feasibility and/or site identification activities • May negotiate clinical trial agreements and budgets • Contribute to other areas of the business as required

🎯 Requirements

• Bachelor’s degree in life sciences, healthcare, or a related biological discipline, or an equivalent combination of education, training, and relevant experience • Minimum of 3 years of experience in drug development and/or clinical research • Minimum of 2 years of experience in a similar role, or an equivalent combination of education, training, and experience in the CRO/pharmaceutical industry • Fundamental knowledge of GxP, privacy legislation (GDPR and/or HIPAA), and applicable local regulatory requirements preferred • Fundamental knowledge of the competent authority submission process, reporting requirements, and guidelines applicable to the country or region • Strong written and verbal communication skills, including a good command of English • Ability to work in a fast-paced, challenging environment within a growing company • Professional, outgoing, and client-focused • Strong organizational and time-management skills • Strong attention to detail and accuracy • Proficiency in computer applications such as Microsoft Word, Excel, and PowerPoint required