Associate Director, Clinical Operations (Trial Master File)

TalentSphere Staffing Solutions; White Rock; On-site; CAD 140,000 - 170,000; Full time

Job summary

A clinical-stage biopharmaceutical company is seeking an Associate Director, Clinical Operations to lead TMF systems and ensure compliance across clinical programs. The ideal candidate will possess deep TMF oversight experience, strong collaboration skills, and a solid grasp of regulatory expectations. This permanent, full-time role is situated in Greater Vancouver, BC, and demands a commitment to operational excellence and a passion for improving patient outcomes.

Benefits

Annual performance bonus

Stock options

Comprehensive medical, dental, and vision benefits

Retirement savings program with company matching

Generous time off including vacation and personal days

Tuition reimbursement

Access to a Learning & Development platform

Qualifications

• Minimum 8+ years of clinical operations or TMF management experience within pharmaceutical, biotechnology, or CRO environments.
• Strong knowledge of ICH-GCP guidelines and global clinical trial regulations.
• Proven ability to collaborate across teams and manage competing priorities.

Responsibilities

• Lead the design, implementation, and management of TMF-related documentation.
• Serve as the subject matter expert (SME) for the electronic Trial Master File (eTMF) system.
• Oversee TMF setup, maintenance, archival in accordance with ICH-GCP.

Skills

Collaboration

Organizational Skills

Communication

Analytical Skills

Attention to Detail

Education

Bachelor’s degree in Life Sciences or related discipline

Job description

Title:Associate Director, Clinical Operations (Trial Master File)
Location: Greater Vancouver On-Site
Position: Permanent, Full-Time
Workplace Type: On-site
Reports To: VP of Operations
Salary Range:$140,000 to $170,000 per annum

Who We Are:
We are a clinical-stage biopharmaceutical company dedicated to discovering, developing, and commercializing innovative therapeutics that address unmet medical needs. With a strong foundation in scientific excellence, we are building a robust pipeline focused on transformative treatments for patients suffering from serious conditions. Our team is driven by curiosity, collaboration, and a shared mission to make a meaningful impact in patients' lives.

What We Do:
We are advancing a diverse portfolio of drug candidates across multiple therapeutic areas, with a strategic focus on leveraging our scientific expertise, cutting-edge technologies, and collaborative partnerships. Our programs span early discovery through to late-stage clinical development, with ongoing efforts to prepare for regulatory filings and commercialization. Our integrated teams work cross-functionally to move programs forward with efficiency, scientific rigor, and patient-centricity.

About the Role:
We are seeking an Associate Director, Clinical Operations (Trial Master File) to join our growing Clinical Development team. This role will be instrumental in leading the strategic planning and operational oversight of our Trial Master File (TMF) systems, ensuring inspection readiness and compliance across all clinical programs.
The ideal candidate will bring deep experience in TMF oversight, clinical documentation, and cross-functional collaboration, as well as a strong understanding of regulatory expectations in a global development environment.
This position is based in Vancouver, BC, Canada, and reports to the Vice President, Trial Operations. The level and compensation for this role will be commensurate with the candidate’s experience and qualifications.Key Responsibilities:

• Lead the design, implementation, and management of TMF-related documentation including SOPs, work instructions, job aids, and guidance materials.
• Serve as the subject matter expert (SME) for the electronic Trial Master File (eTMF) system, providing cross-functional leadership and training on TMF best practices.
• Oversee setup, maintenance, review, and archival of TMFs in accordance with ICH-GCP, regulatory requirements, and company standards.
• Drive the selection and integration of new TMF platforms, collaborating with vendors and internal stakeholders to ensure operational success.
• Monitor TMF performance metrics to ensure documentation accuracy, completeness, and timeliness; identify and address gaps proactively.
• Oversee TMF QC activities and ensure readiness for internal audits and regulatory inspections.
• Partner with Clinical Study Teams, CROs, and functional stakeholders to maintain TMF quality throughout the clinical trial lifecycle.
• Lead TMF inspection preparedness and represent TMF during audits/inspections.
• Develop collaborative relationships across departments (e.g., Regulatory, Biometrics, Drug Supply, Safety) to support TMF operations.
• Contribute to continuous improvement initiatives, driving operational excellence and compliance across clinical documentation processes.
• Act in alignment with company policies and ethical standards.

Qualifications:

• Bachelor’s degree in a relevant field (Life Sciences, Health Sciences, or related discipline); advanced degrees or certifications are a plus.
• Minimum 8+ years of clinical operations or TMF management experience within pharmaceutical, biotechnology, or CRO environments.
• Strong knowledge of ICH-GCP guidelines and global clinical trial regulations (e.g., FDA, Health Canada, EMA).
• Demonstrated experience with TMF systems, clinical documentation strategy, and inspection readiness.
• Experience managing TMF transitions and implementing new eTMF platforms preferred.
• Proven ability to collaborate across teams and manage competing priorities in a dynamic environment.
• Excellent organizational, communication, and analytical skills.
• High level of integrity, professionalism, and attention to detail.
• Willingness to travel up to 15% (domestic and international).

Compensation & Benefits:

• Base Salary Range: $140,100 – $170,000 CAD

Our Total Rewards package includes:

• Competitive base salary, annual performance bonus, and stock options
• Comprehensive benefits: medical, dental, vision, life, disability, travel insurance, and employee assistance programs
• Retirement savings program with company matching
• Generous time off: vacation, personal days, sick leave, and company-wide year-end shutdown
• Tuition reimbursement and access to an expanding Learning & Development platform

To Apply:
Contact Haidun Liu, Senior Associate, TalentSphere – Life Sciences, [e-mail]. To apply, please use the TalentSphere job board -https://jobs.talentsphere.ca/

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Job Posting ID:#16668112