Clinical Safety Associate I
1 DNA Way, SSF01 South San Francisco, CA 94080
Bayside Solutions is seeking a Clinical Safety Associate I to be part of our client’ s team South San Francisco. 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.
Clinical Safety Associate 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:
- The Clinical Data Coordinator will be an integral contributor to the Clinical Data Management team for review of safety data in the clinical trial. The successful candidate should be a motivated, self-starter with the experience to provide data management support and input within a cross-functional team and contribute to the direction of data management solutions.
- Accountable for all study related activities under the scope of USMA
- Under the direction of Study Data Manager, perform safety data review and safety data reporting activities for one or more clinical studies to ensure productivity and progress
- Accountable for the design and implementation of the Safety reporting tools using Spotfire
- Accountable for daily review of safety data and preparation of safety coversheet along with safety reports
- Communicate with various stakeholders such as Drug safety and PDSO for resolution of issues pertaining to the safety data
- Proactively conducts ongoing safety data review throughout the conduct of the study to ensure timely and appropriate identification of errors, trends, and discrepancies
- Responsible for the oversight of identifying, creating additional, or updating existing local Guidance Documents including but not limited to training matrix, identify appropriate target audience for training assignment
- Collaborates with other key stakeholders to provide expertise and guidance for interdepartmental and cross-functional team activities, including process improvement standards and metrics
- Liaises with Program Data Management (PDM) across one or more CDM study teams in order to implement standards
- Communicates study timelines and deliverables to all CDM study team staff and follows up to ensure timely delivery of assigned tasks
- Responsible for correction of errors and discrepancies through the site query process, for documenting permanent data issues, routinely communicating issues with team members and the delivery of a quality locked database for analysis
- Perform other duties as assigned
Summary of Qualifications:
- A minimum of 4 year Science (Biological Science) degree or equivalent in scientific, medical or relevant clinical discipline or a qualified healthcare professional required
- CCDM (Certified Clinical Data Manager through the Society for Clinical Data Management (SCDM) preferred
- A minimum of 3 – 5 years’ experience
- 2+ years of safety data review experience in biotechnology or pharmaceutical industry
- 2+ years of Electronic Data Capture (EDC) experience; IXRS integration is a plus
- GCP and regulatory knowledge including FDA and ICH regulations; exposure to GDPR regulations is a plus
- Moderate practical and theoretical expertise within the sub function
- An understanding of the business of his or her sub function and greater CDM organization
- Technical proficiency and ability to complete complex assignments within defined parameters
- Ability to identify a range of problems and escalate appropriately
- Contribution to the awareness and education of fellow colleagues by sharing information and learnings from attendance at conferences and educational enrichment activities
- Ability to represent at industry user groups and conferences leveraging net-working opportunities