Remote Coordonnateur(trice) de la documentation TMF II/TMF Document Coordinator II

Indero; Conception Bay South; Remote; CAD 65,000 - 90,000; Full time

Benefits offered by this job

Flexible work schedule

Permanent full-time position

Company benefits package

Ongoing learning and development

Home-based position

Job summary

Indero is a global clinical CRO specializing in dermatology and rheumatology. The TMF Document Coordinator II will support TMF maintenance, ensure quality and regulatory compliance, and lead TMF activities for IIS and smaller studies.

The role requires a college degree, 1+ year in clinical research, and strong English proficiency. The position is home-based in Canada with a flexible schedule and comprehensive benefits.

Qualifications

• College degree is required.
• At least 1 year of clinical research experience in biotech/pharma/CRO.
• Advanced proficiency in English.
• Knowledge of TMF Reference Model and eTMF technologies.
• Computer skills with Microsoft Word and Excel.
• Strong organizational skills and ability to manage multiple tasks.
• High attention to detail and accuracy.
• Good communication skills.
• Ability to meet timelines and objectives.
• Adaptable to multitasking and changing priorities.
• Knowledge of GCP and Health Canada/FDA guidelines.

Responsibilities

• Review TMF records for completeness, accuracy and quality before approval.
• Classify records and assign metadata per sponsor requirements and regulatory standards.
• Identify quality issues and coordinate with submitters for timely resolutions.
• Participate in TMF quality reviews and address findings.
• Maintain study milestones and document lists.
• Generate TMF metrics and reports for the TMF Project Lead.
• Attend TMF Focus meetings and report status and queries.
• Collaborate with cross-functional teams to resolve TMF issues.
• Lead TMF activities for IIS and limited-scale sponsored studies.
• Oversee eTMF from start to closeout; develop TMF Plan and TMF Index.
• Create and maintain study milestones and document lists.
• Prepare TMF performance metrics and escalation reports.
• Coordinate TMF activities and deliverables; lead internal focus meetings.
• Manage TMF closeout with cross-functional teams.
• Possible contributions to process improvements.

Skills

TMF knowledge

English proficiency

MS Word & Excel

Attention to detail

Communication skills

Organizational skills

Time management

GCP/Regulatory knowledge

Multitasking

Education

College degree

Tools

eTMF platforms

TMF Reference Model

Job description

The TMF Document Coordinator II plays a key support role in maintaining the Sponsor’s Trial Master File (TMF) throughout the duration of a clinical trial. The TMF Coordinator II reviews and processes TMF records through quality control workflows to ensure they meet required quality, compliance, and regulatory standards before being approved into the TMF, following study-specific guidelines, SOPs, and ICH‑GCP requirements. In addition to performing all core TMF review and quality control activities, the TMF Document Coordinator II independently leads TMF activities for Investigator‑Initiated Studies (IIS) and Sponsored Studies of limited scale and complexity.

TMF Document Coordinator II must:

• Review TMF records for completeness, accuracy, and quality prior to approval in the TMF.
• Classify records and assign appropriate metadata based on record type in compliance with sponsor requirements, internal tools/procedures, and global regulatory standard.
• Identify quality issues, issue pre‑approval queries, and coordinate with submitters to ensure timely resolution.
• Participate in or perform TMF quality reviews and address assigned findings promptly.
• Assist in maintaining study milestones and expected document lists.
• Support the TMF Project Lead in generating monthly TMF metrics and related reports.
• Attend internal TMF Focus meetings to provide updates on TMF status, issues, and outstanding queries.
• Collaborate with project team members to resolve issues impacting TMF records. Escalate recurrent or unaddressed issues to TMF Project Lead, as required.
• Lead TMF activities for Investigator‑Initiated Studies (IIS) and Sponsored Studies of limited scale and complexity, including additional responsibilities such as:

1. Oversee the eTMF from study start to study closeout.
2. Develop and maintain the TMF Management Plan and TMF Index.
3. Create and maintain study milestones and expected document lists.
4. Prepare TMF performance metrics; monitor trends and escalation issues as needed.
5. Generate reports to support identification of missing TMF records.
6. Coordinate TMF activities and deliverables (i.e., periodic completeness and quality reviews)
7. Lead internal TMF Focus Meetings.
8. Manage TMF closeout activities in collaboration with cross-functional teams.

• May contribute to process improvement initiatives.
• May assist with administrative activities related to the management of computerized systems (e.g., user access administration and periodic reviews).

The TMF Document Coordinator II may be assigned to other responsibilities that do not pertain to their former description, if they have the required experience, are qualified and/or have received adequate training.

• 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.

The work environment

At Indero, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities.

In this position, you will be eligible for the following perks:

• Flexible work schedule
• Permanent full-time position
• Company benefits package
• Ongoing learning and development
• Home-based position

About Indero

A Global Clinical Leader in Dermatology and rheumatology!

Formerly known as Innovaderm, Indero is a world‑renowned expert and clinical research leader in dermatology. We have more than two decades of experience serving a broad range of indications, patient populations, administration routes, and drug classes, and a global footprint.

Indero is a dual‑focus CRO for dermatology and rheumatology, with 25+ years’ experience in clinical research and trial delivery. Our full‑service approach – which includes everything from protocol design and patient recruitment to trial monitoring and biometrics – provides biotech and pharmaceutical sponsors with the rigorous scientific foundation and tailored expertise their studies need to reach the finish line efficiently and effectively. With capabilities in North America, Europe, Asia Pacific and Latin America; vast, continuously growing relationships with investigators and patients; and a dedicated research clinic through which we design and execute our own studies, Indero is the ideal CRO partner for clinical needs at global scale.

Indero is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request.

Indero only accepts applicants who can legally work in Canada.

L’environnement de travail

Chez Indero, vous travaillerez avec des collaborateurs compétents et dynamiques. Nos valeurs sont la collaboration, l’innovation, la fiabilité et la réactivité. Nous offrons un environnement de travail stimulant et des possibilités d’avancement intéressantes.

Dans ce rôle, vous bénéficierez des avantages suivants :

• Horaire de travail flexible
• Poste permanent à temps plein
• Avantages sociaux complets (soins médicaux, soins dentaires, soins de la vue, REER, vacances, jours personnels, clinique médicale virtuelle, rabais sur le transport en commun, activités sociales)
• Formation et perfectionnement continu

À propos Indero

Anciennement connu sous le nom d’Innovaderm, Indero est un expert de renommée mondiale et un chef de file en recherche clinique en dermatologie. Nous comptons plus de vingt ans d’expérience couvrant un vaste éventail d’indications, de populations de patients, de voies d’administration et de classes de médicaments, avec une présence à l’échelle mondiale.

Indero est un CRO à double spécialisation en dermatologie et en rhumatologie, cumulant plus de 25 ans d’expérience en recherche clinique et en réalisation d’essais cliniques. Notre approche de services complets — allant de la conception des protocoles et du recrutement des patients à la surveillance des essais et à la biométrie — offre aux promoteurs des secteurs biotechnologique et pharmaceutique la rigueur scientifique et l’expertise sur mesure nécessaires pour mener leurs études à terme de façon efficace et performante. Grâce à nos capacités en Amérique du Nord, en Europe, en Asie‑Pacifique et en Amérique latine, à nos relations étendues et en constante évolution avec les investigateurs et les patients, ainsi qu’à une clinique de recherche dédiée où nous concevons et réalisons nos propres études, Indero est le partenaire CRO idéal pour répondre à des besoins cliniques à l’échelle mondiale.

Indero s’engage à offrir un traitement équitable et l’égalité des chances à toutes les personnes. À ce titre, Indero offre, sur demande, des mesures d’adaptation aux candidats en situation de handicap tout au long du processus de recrutement et de sélection.

Indero accepte uniquement les candidats pouvant légalement travailler au Canada.

Le genre masculin est utilisé sans discrimination et dans le seul but d’alléger le texte.