job summary: As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. Internationally known for creating cutting-edge biopharmaceuticals for patients who live with rare genetic diseases, our partner strives to develop critical therapies for the small population - mostly children - that suffer from near unheard of conditions. If you're looking for an exciting opportunity to make a difference with an established company, this is the position for you!
location: San Rafael, California
job type: Contract
salary: $30.34 - 35.70 per hour
work hours: 9 to 5
- Work to TMF Management Plans and TMF Content Lists
- Participate in the Quality Control of documents (paper and electronic) submitted to the TMF or eTMF
- Facilitate the review and submission of TMF records to Records Management personnel
- Act as point person for Study Team TMF questions and manage close-out of TMF related issues in adherence to BioMarin processes
- Support the Study Team in TMF document retrieval during Audits and Inspections (paper and electronic)
- Manage the TMF content list and TMF Comprehensive Review tracker
- Provide TMF metrics: completeness and quality of TMF documentation and content, including the percent completeness and the risk level of outstanding items on a periodic basis or as requested by DevSci management
- Participate in the conduct of quality review of the TMF for each assigned study on an annual basis per the time points captured in the study-specific TMF Plan.
- Identify any corrective actions which must be addressed and assigned
- Support the submission of documented evidence of the TMF Quality Review to the TMF
- Support the management of TMF documentation issues throughout the lifecycle of an assigned study
- Participate in the implementation of standards and processes for DevSci records management to verify compliance with relevant regulations
- Support and carry out the processes associated with the storing, archiving, indexing, scanning and classifying records:
- Process records (e.g., track, scan, archive) in compliance with DevSci Records SOPs
- Prepare and maintain manuals, training materials, policies and procedures and other quality documents as they apply to the management of records in DevSci Records
- Provide guidance on best practices for record handling, retrieval and archival procedures
- Provide archived DevSci records to users (e.g. internal staff and/or Auditors) for review. Oversee the provision of the required documents at the time of Regulatory Authority Inspection or internal Audits
- Respond to TMF and non-TMF internal and/or external information inquiries related to DevSci records
- Participate in the development, implementation, and maintenance of classification and filing systems per administrative, research, regulatory, legal and financial requirements
- Manage the off-site storage of DevSci records and the contract with the storage vendor, including vendor oversight
- Participate in the development, implementation, and maintenance of internal databases used to manage records
- Responsible for filing, tracking, retrieving, storing, and organizing archival GLP documentation and records (paper and electronic)
- Ensure that archived GLP documentation and records (paper and electronic) are accurately catalogued and filed for expedient retrieval
- Serve as GLP archive staff member and backup to primary GLP Archivist
- May support health authority (e.g. FDA, EMA, etc.) inspection readiness, preparation, and conduct
qualifications: Education & Qualifications:
- Bachelors Degree or 1 year of experience
- Familiarity with GLP and GCP regulations and best practices
- Experience working in a GCP and GLP environment preferred
skills: Clinical Data Management
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.