About Cerus:
Cerus aims to be the global leader and trusted partner of blood centers and hospitals whose technology, services, and commitment are the lifeblood of safe and accessible blood for patients around the world.
Summary & Scope of Position:
Manage and maintain Trial Master Files (TMFs) in a state of inspection readiness and support regulatory submissions and inspections.
Primary Responsibilities:
- Work with multi-functional study teams to ensure the maintenance of TMFs, both electronic and paper, in a state of inspection readiness.
- Perform vendor oversight of third-party electronic TMF vendors, including leading implementation and ongoing activities both internally and externally.
- Create and maintain study specific TMF Management Plan in collaboration with the Clinical Trial Manager.
- CRO oversight as it relates to TMF management collaboration with the Clinical Trial Manager.
- Create and manage internal budgets for all TMF related activities
- Work with management to manage budgets for CRO contracted TMF related activities
- Manage conduct of TMF quality reviews by cross-functional study team; driving to closure quality review findings.
- Support the functional owners in the identification and management of the collection of study specific TMF content, (both sponsor and CRO).
- TMF migration oversight and project management.
- Develop training materials and conduct employee onboarding training for eTMF systems (Veeva) and filing of training documentation and is securely and properly preserved in Cerus document control system.
- Performs independent quality check of TMF.
- Acting TMF subject matter expert (SME)/ point of contact for study teams and TMF stakeholders.
- Perform inventory activities for on-site and off-site storage records.
- Author and provide input on the revision of TMF related Work Instructions and SOPs.
- Provide support and TMF guidance in, audits and/ or inspections.
- May supervise staff including onboarding, training, development and performance management.
Qualifications/Requirements/Skills:
- At least 7 years of relevant records management/ TMF management experience.
- Veeva Clinical Vault eTMF Business Admin or a combination of eTMF systems administration experience.
- Experience must include managing the following short list of responsibilities:
- Change Control
- Software release updates
- Users and user groups
- Onboarding, refresher and task specific training
- TMF content organization
- Vault functionality
- Object lifecycles
- Document types, document fields, and general settings
- Inspection and audit experience required
- Direct line management experience required
- Comprehensive understanding of the clinical study phases involved in drug development and their corresponding records requirements.
- Thorough knowledge and understanding of technical aspects of standard eTMF systems
- Knowledge of FDA and other global clinical trial regulations, as well as detailed knowledge of ICH and FDA GCP guidelines related to Clinical Document Management. Experience in medical device and compliance with ISO 14155 desired.
- Ability to collaborate with study teams to establish and determine TMF requirements.
We understand that our people are essential to our success. This philosophy is revealed in our competitive benefits package, designed to improve employees’ lives both on and off the job.
Benefits plans: medical, dental, vision, domestic partner benefits, paid maternity and paternity leaves, healthcare and dependent care flexible spending, life and accidental death insurance, long-term and short-term disability insurance, matching 401(k), ESPP, RSUs
Work and family: EAP, legal and financial services, health club membership discounts, tuition reimbursement
Compensation: The base salary range for this position if candidate is based out of the SF bay area: $150,000-$175,000 annually. Compensation may vary outside of this range depending on various factors, including a candidate’s qualifications, skills, competencies, experience, and location. Base pay is one part of the total package to compensate and recognize employees for their work.
All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.
