Documentation Specialist I
4300 Hacienda Dr Pleasanton, CA 94588
Bayside Solutions is seeking a Documentation Specialist I to be part of our client’ s team in the Tri Valley. This is an opportunity to work with the largest privately held pharmaceutical corporation in the world and ranks among the world' s 20 leading pharmaceutical corporations.
Our Client’ s culture is highly collaborative, offers an environment that encourages employees to expand their knowledge in order to make a profound impact on patients’ lives. This could explain why their company has been recognized as one of the “ Top Twenty Employers” in biotechnology and pharmaceuticals by Science Careers.
Our Company Bio: Bayside Solutions was founded in 2001, Bayside was recognized as one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.
You can find additional information on our company website at www.baysidesolutions.com
Documentation Specialist I
- An opportunity to join a patient-focused organization that is driven to develop, manufacture and commercialize medicines to treat life threatening conditions.
- Work for a company that is local to the bay area and recognized as a leader of innovation.
- Competitive compensation commensurate with experience.
- This position is eligible for medical, vision, dental benefits, paid sick time, and 401K.
Summary of Responsibilities:
- Reviewing all documents in assigned study files to ensure they are filed appropriately and meet required quality standards.
- Setting up the eTMF (electronic Trial Master File) per study specifications.
- Archival of eTMF documents at the conclusion of a study.
- Subject matter expert for end-to-end eTMF process, structure and content, including providing document retrieval support during regulatory audits and inspections.
- Running system reports to assess eTMF health, including interpretation, delivery and follow-up with stakeholders.
- Contributing to process improvement activities.
Summary of Qualifications:
- Associate or 4-year degree in Biological/Life Science or equivalent is preferred
- Proficient knowledge of Good Clinical Practice (GCP), Good Documentation Practice (GDP), and required clinical study documentation, or the capacity to develop this knowledge.
- High school diploma or equivalent.
- Minimum of 5 years of relevant experience, including 3 years of Trial Master File experience.
- Independent time management and ability to balance multiple priorities.
- Demonstrated ability to learn new software/tools rapidly.
- Must have strong attention to detail.
- Strong customer orientation and a proven track record in working closely with others