Study Start-Up Specialist II
620 E Grand Ave., SSF45 South San Francisco, CA 94080
Bayside Solutions is seeking a Study Start-Up Specialist II to be part of our client’ s team in 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.
Study Start-Up Specialist II
- 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 Study Start-up Specialist (SSUS) is responsible for all SSU-related activities in the country/region, on assigned studies, overseeing and leading SSU activities in collaboration with other clinical research stakeholders.
- Updates knowledge on related regulatory requirements, ensures adherence and compliance with local regulations and internal procedures.
- Executes all start-up activities prior to site activation on assigned studies, according to client standards and aligned with study/project requirements and timelines.
- Prepares country level Informed Consent Form (ICF) and obtains ethics committees’ and local regulatory authorities’ approval. Prepares ongoing submissions, amendments and periodic notifications required by ethics committees and regulatory authorities as needed within the country.
- Maintains and analyzes study start-up data (metrics) on assigned studies, ensuring optimal efficiency to reduce start-up timelines and identify opportunities for continuous improvement.
- Partners with Clinical Study Managers (CSM5) and Clinical Study Specialists (CSSs) to provide guidance on regulatory/ethics requirements, to track and drive site activations and trial amendments submissions, by regularly reviewing and monitoring status of submissions/activations.
- Supports drug label preparation and approval (as local label representative) for studies in collaboration with local Regulatory/Quality department, as required.
- Liaises and collaborates with relevant authorities/bodies to further enhance clinical trial process, government policies! laws, via innovative approaches
- Submits, according to local regulatory requirements, all Suspected Unexpected Serious Adverse Reactions (SIJSAR5), Six Monthly SUSAR Reports (SSRs) and Development Safety Update Reports (DSURs).
- In collaboration with CSMs, identifies and tracks new investigator sites performing feasibility, as applicable, and develops and supports effective patient recruitment and retention practices, as required.
- Responsible for study budget and contracts negotiation in collaboration with Contracts Manager/Associate, as required and ensures compliance with Fair Market Value (FMV) in the country.
Summary of Qualifications:
- University Degree or equivalent, preferably in a medical/science-related field.
- Demonstrated knowledge and understanding of clinical trials and experience in managing projects.
- Demonstrated knowledge and understanding of International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use, Good Clinical Practices (ICH-GCP), as well as understanding of the regulatory, ethics and contractual requirements for starting clinical trials in the relevant country.
- Previous line management experience/supervision of staff is preferred.
- Demonstrated competence in analysis, planning and problem solving.
- Excellent communications skills including the ability to state opinions clearly, ask questions, seek clarification, communicate facts objectively, challenge when appropriate, and pursue issues to resolution
- Ability to present clear messages from complex information/data to all levels in the organization in both written and spoken English
- Experience working as part of a team with a proven ability to make an active contribution to the team' s performance and teamwork
- Able to make effective decisions, self-motivated, assertive, and displays initiative
- Proven project management and organizational skills and the ability to prioritize and manage multiple tasks with flexibility
- Demonstrated computer literacy, usage of MS Office software, web-based systems and databases.