Sr. Clinical Study Associate
350 DNA Way, SSF35 South San Francisco, CA 94080
Bayside Solutions is seeking Sr. Clinical Study Associate 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.
Sr. Clinical Study Associate
- 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 role purpose as the Sr. Clinical Study Associate (CSA) is responsible for providing operational support to multiple study teams through all phases of clinical study management (Plan, Start-up, Conduct, and Close-out) in accordance with appropriate quality standard including ICH/GCP and applicable regulations.
- Mentoring of junior level clinical study associate
- Communicate with internal team members and CROs regarding start-up, maintenance, and close out activities.
- In collaboration with Clinical Study Manager, assists in the oversight of vendor activities along with the CROS.
- Oversight/support of some CRO activities, such as:
- Receive regulatory documents for review and submissions to the Regulatory Department.
- Develop TMF plan and manage through transfer of documents to the sponsor.
- Provides guidance with development of the clinical trial bingers for study sites.
- Manage and track study specific payments and invoices.
- Provides support for investigator meeting planning, including organizing meeting materials and provide onsite meeting assistance as needed.
- Oversee CRO tracking systems and tools to support the conduct of a clinical trial from the startup to close out phase.
- Provides support to CSM on startup activities
- Review and collaborate with CSM on the development of certain study specific plans and/or processes (e.g., satellite site management plans or drug destruction memos)
- Collaboratively work with CROs to ensure the CTMS has current updated information.
- Manage and track vendor specific payments and invoices
- Assist with maintaining tracking and reporting study metrics. Coordinates with Clinical Study Manager to communicate relevant trial information between various internal functional members and contract vendors.
- Manage tracking and delivery of clinical/non-clinical supplies
- Generate and review trail management reports from internal tracking systems at requested intervals.
- Conduct timely review of clinical trial documents upon request
- Review Informed Consent documents as well as Monitoring Visit Report Review (PSSV, SIV, IMV and COV)
- Provide support to both internal and external departmental members when necessary.
- May serve as subject matter expert on task forces, initiatives, and working groups.
- Some travel may be required.
- Bachelor’ s degree or equivalent.
- A minimum of 5 years in clinical research or health related industry is required.
- Highly effective verbal and written communication skills; effectively delivers key messages; aptitude to independently communication with teams and stakeholders.
- Demonstrates an aptitude to distill information from the multiple sources to create meaningful insights and induces collaboration and innovative thinking study-wide.
- Experience with effective vendor management preferred.
- Demonstrates an aptitude for strategic thinking skills; manages ricks (including risk identification and migration); identifies critical path/critical dependencies.
- Strong customer focus with functional peers, vendors, country affiliates, etc.
- Excellent planning and organizational skills.
- Ability to build trusting and collaborative relationships that promote innovation, knowledge-sharing and adaptation to change.
- Practices the ability to influence and negotiate to achieve team goals.
- Consistently supports change in an effort to continue to develop USMA’ s dynamic organization.
- Demonstrates creativity and innovation to support projects and initiatives.
- Strong technical and analytical skills and ability to manage system data maintenance across multiple systems.
- Aptitude to interpret outputs from analytical tools to enhance and improve study execution.
- Self-motivated, achievement-driven and exhibits ability to work with minimal guidance.