- Manages assigned parts (vendor and/or global region) of studies of large scope and high complexity
- Assists with the development of department initiatives, process documents and standard forms
- Assist in review of study documents (ICFs, plans, forms, trip reports, etc.)
- Interacts with the study team and other departments with within the company to complete assigned tasks
- As needed, arranges meeting logistics, agendas and assist with minutes
- As needed, tracks, analyzes, and prepares study-specific information utilizing databases, spreadsheets, and other study tools
- Serve as a back up to the Clinical Trial Manager and team
- May lead a component of a routine clinical study such as TMF review
- May conduct, with oversight, site evaluation, initiation, monitor or co-monitor study sites, performing routine data collection, source data verification, and review of routine regulatory documents/files in compliance with protocol, regulatory requirements, SOPs and Monitoring Plan, as required
- Mentors and supports more junior team members (CPA)
- Travels as required. 10-20% domestic
- Bachelor's Degree or equivalent experience
- 2 years of clinical trial experience within clinical operations at a biotech or pharmaceutical company
- Collaborative demeanor
- Exceptional organizational skill and communication skills, both spoken and written with the ability to plan, organize, and prioritize multiple work assignments and goals
- Strong ability to work with cross-functional team members and external vendor
- Working knowledge and experience with Word, PowerPoint, and Excel
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Clinical Trial Manager Associate - Brisbane, United States - Vera Therapeutics
Description
Job Description
Job DescriptionTitle: Clinical Trial Manager Associate
Location: Brisbane, CA
About Us:
Vera Therapeutics (Nasdaq: VERA), is a late-stage biotechnology company focused on developing treatments for serious immunological diseases. Vera's mission is to advance treatments that target the source of immunologic diseases in order to change the standard of care for patients. Vera's lead product candidate is atacicept, a fusion protein self-administered as a subcutaneous injection once weekly that blocks both B lymphocyte stimulator (BLyS) and a proliferation inducing ligand (APRIL), which stimulate B cells and plasma cells to produce autoantibodies contributing to certain autoimmune diseases, including IgA nephropathy (IgAN), also known as Berger's disease and lupus nephritis. In addition, Vera is evaluating additional diseases where the reduction of autoantibodies by atacicept may prove medically useful. Vera is also developing MAU868, a monoclonal antibody designed to neutralize infection with BK Virus, a polyomavirus that can have devastating consequences in certain settings such as kidney transplant. For more information please visit:
Our values are the cornerstone of our culture. Our values inspire us every day and guide everything we do—from how we hire great people, to advancing our mission together, to achieving our ultimate goal to improve medical treatment for patients suffering from immunological diseases.
Position Summary:
The Clinical Trial Manager Associate will report to the Senior Director, Clinical Operations and will be responsible for providing support to the clinical operations study teams for assigned responsibilities of a study/studies.
Responsibilities:
Qualifications:
Vera Therapeutics Inc. is an equal opportunity employer.
Vera Therapeutics is committed to fair and equitable compensation practices, and we strive to provide employees with total compensation packages that are market competitive. For this role, the anticipated base pay range is $106,000- $132,000. The exact base pay offered for this role will depend on various factors, including but not limited to the candidate's geography, qualifications, skills, and experience.
At Vera, base pay is only one part of your total compensation package. The successful candidate will be eligible for an annual performance incentive bonus, new hire equity, and ongoing performance-based equity. Vera Therapeutics also offers various benefits offerings, including, but not limited to, medical, dental, and vision insurance, 401k match, flexible time off, and a number of paid holidays.
COVID-19 Policy
Vera's top priority is the health and safety of our employees, their families and the communities where they live and work. As part of our commitment to health and safety, we require all U.S. employees to be fully vaccinated against COVID-19. If your role at Vera requires you to work or otherwise be on Vera's premises, full or part-time, we require our employees to comply with Vera's mandatory COVID-19 vaccination policy (currently requiring full vaccination). Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, may request a reasonable accommodation with Human Resources. Your employment is also subject to ongoing compliance with the mandatory vaccination policy and all other Vera policies, as they may be modified from time to time, at the sole discretion of Vera.
Notice to Recruiters/Staffing Agencies
Recruiters and staffing agencies should not contact Vera Therapeutics through this page. All recruitment vendors (search firms, recruitment agencies, and staffing companies) are prohibited from contacting our hiring manager(s), executive team members, or employees.
We require that all recruiters and staffing agencies have a fully executed, formal written agreement on file.
Vera Therapeutics' receipt or acceptance of an unsolicited resume submitted by a vendor organization to this website or employee does not constitute an actual or implied contract between Vera Therapeutics and such organization and will be considered unsolicited and Vera Therapeutics will not be responsible for related fees.
