- Act as the single point of contact for all data management deliverables, overseeing CDM activities across multiple studies
- Represent CDM in cross-functional meetings
- Cultivate effective and productive working relationships with peers, management and vendors
- Develop timelines for data cleaning processes that maintain data integrity
- Provide input into the development of vendor/contract research organization (CRO) request for proposal, scope of work, budget negotiations, and onboarding
- Lead and manage CDM vendor/(CRO) service activities in a fully outsourced model from study build to database lock
- Ensure complete and accurate CDM documentation on any given study
- Participate in study document reviews, such as, clinical study protocols, statistical analysis plans, risk management plans, monitoring plans and analysis output review
- Manage and provide oversight for clinical data flow with CRO and ancillary vendors including IXRS, eCOA, central lab, imaging, and other systems and services, as needed
- Manage and provide oversight to the CDM section of the Trial Master File
- Help develop company SOPs and work instructions
- Participate and support DM related activities associated with regulatory inspections/audits
- Assist with strategic planning activities for the CDM department
- Provide or present CDM plans, status or reports to a broad audience
- Maintain awareness of CDM emerging trends and technology to help develop or enhance CDM department standards, operational procedures, and best practices
- Bachelor's degree with at least eight (8) years of relevant industry experience
- Very detail-oriented, thorough, and organized
- Demonstrated project management experience with ability to perform under tight timelines whilst balancing conflicting priorities
- Versatile communicative and strong interpersonal skills
- Ability to work effectively in both a team setting and independently
- Knowledgeable in GCP standards, CDISC standards (CDASH, SDTM, ADaM), FDA and ICH guidelines, and recommended CDM Best Practices
- Knowledgeable in data privacy requirements for data collection of clinical trial data and information
- Proficient in Medidata Rave and/or other EDC platform study builds
- Experience working with and managing CROs/external vendors
- Experience with writing SOPs, work instructions and guidelines preferred
- Experience with NDA/BLA activities preferred
- Experience with regulatory inspection/audit preparation preferred
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Senior Manager, Clinical Data Management - Brisbane, United States - Vera Therapeutics
Description
Job Description
Job DescriptionJob Title: Senior Manager, Clinical Data Management
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 Data Management (CDM) department plays an integral role as part of the cross-functional study team. Clinical Data Management is responsible for the collection, organization, and integrity of data collected as part of our clinical trials.
Reporting to the Executive Director, CDM, the Senior Manager, CDM will be a highly motivated, quality-focused individual who can work collaboratively in a fast-paced, cross-functional team environment, and will oversee data management activities across multiple studies from study start-up through study closure in support of clinical trial objectives and corporate goals.
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 $176,000 - $202,000. 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.
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.
