Document Coordinator II

Job not on LinkedIn

🔥 0 minutes ago

🇨🇦 Canada – Remote

⏰ Full Time

🟢 Junior

👻 Ghost score 12%

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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Innovaderm Research Inc.

WebsiteLinkedInAll Job Openings

201 - 500 employees

💊 Pharmaceuticals

🏥 Healthcare

💼 Consulting

Pharmaceuticals • Healthcare • Consulting

Innovaderm Research Inc. is a Contract Research Organization (CRO) specialized in dermatology, providing scientific guidance and conducting Phase I to IV clinical trials in the field. With a strong presence in North America and Europe, Innovaderm offers a comprehensive range of services including study design, regulatory consulting, project management, patient recruitment, and data management, ensuring high-quality research outcomes and customer satisfaction since 2000.

📋 Description

• Maintain the Sponsor’s Trial Master File throughout the duration of clinical trials. • Review TMF records for completeness, accuracy, and quality before approval. • Classify records and assign appropriate metadata according to record type and sponsor requirements. • Identify quality issues, issue pre-approval queries, and coordinate timely resolution with submitters. • Participate in or perform TMF quality reviews and address assigned findings. • Maintain study milestones and expected document lists. • Support the TMF Project Lead with monthly TMF metrics and related reports. • Attend internal TMF Focus meetings and provide updates on TMF status, issues, and outstanding queries. • Collaborate with project teams to resolve issues affecting TMF records and escalate recurring or unresolved issues. • Lead TMF activities for Investigator-Initiated Studies and limited-scale Sponsored Studies. • Oversee the eTMF from study start through closeout. • Develop and maintain the TMF Management Plan and TMF Index. • Prepare performance metrics, monitor trends, and generate reports identifying missing records. • Coordinate TMF activities and deliverables, including periodic completeness and quality reviews. • Lead internal TMF Focus Meetings. • Manage TMF closeout activities with cross-functional teams. • Contribute to process improvement initiatives and administrative activities related to computerized systems when assigned.

🎯 Requirements

• College degree. • At least 1 year experience in clinical research within the biotechnology, pharmaceutical, or CRO industry. • Advanced proficiency in English. • Knowledge of the TMF Reference Model and eTMF technologies. • Computer skills and proficiency in Microsoft Word and Excel. • Good organizational skills with the ability to manage multiple assignments. • High attention to detail and accuracy. • Good communication skills. • Ability to meet established timelines, expectations, and objectives. • Adaptable and comfortable working in a multitasking environment. • Good knowledge of good clinical practices, and applicable Health Canada and Food and Drug Administration (FDA) regulations/guidelines. • Legally authorized to work in Canada.

🏖️ Benefits

• Flexible work schedule • Permanent full-time position • Company benefits package, including medical, dental, vision, RRSP, vacation, personal days, virtual medical clinic, public transit discounts, and social activities • Ongoing learning and development • Home-based position