- Serves as the Data Management Lead on various clinical studies.
- Provides vendor DM oversight and management as needed.
- Ensures that data quality and integrity are maintained from study start through database lock.
- Reviews study protocols and assists in the planning and implementation of the data management portions.
- Leads the design of CRFs/eCRF for sound and thorough data collection through the regulatory approval process.
- Trains other personnel on eCRFs and EDC, as needed.
- Authors and maintains data management documents including Data Management Plans, Data Transfer Plans, and Data Review Plans.
- Lead data review, query management, and data management metrics reporting to ensure completeness, correctness, and consistency.
- Serves as an active member of Clinical Study Teams (CST).
- Works with other functions to develop timelines and ensure DM deadlines are met.
- Works with vendors such as central laboratories in support of timelines and data-related deliverables.
- Ensures laboratory data, if applicable, and associated lab normal ranges are reviewed and reconciled.
- Defines eCRF and edit check specifications as necessary to support data collection and analyses required by the protocol.
- Works closely with database builders during programming of EDC databases, edit checks and reports.
- Drives and performs User Acceptance Testing (UAT) activities for clinical trial database build and modifications.
- Develops study-specific eCRF Completion Guidelines.
- Creates and follows study-specific Data Management Plans.
- Creates and maintains data management documentation.
- Ensures data cleaning activities as specified in the Data Validation Specifications and Data Management Plan.
- Works with the appropriate coding group to ensure medical terminology coding is applied to assigned clinical studies.
- Helps support the implementation of data analytics in support of clinical and medical review of data. Assists in training assigned data reviewers in data review.
- Coordinates with cross-functional team members on serious adverse event reconciliation.
- May participate in the development and maintenance of Standard Operating Procedures (SOPs) and Work Instructions related to data management activities.
- Maintains eTMF for DM documentation and perform archiving of the study database and study documentation.
- Other duties as assigned.
- Bachelor's degree in a scientific subject area preferred
- Minimum 8 years of clinical data management experience in biotechnology or pharmaceutical industry
- Minimum 6 years of Electronic Data Capture (EDC) experience; IXRS development preferred
- Proficient computer skills, including Microsoft Office applications
- Must have strong knowledge of Data Management processes and systems
- Solid understanding of clinical drug development processes required
- Must have demonstrated problem solving abilities in a team environment and strong organizational skills and the ability to work in a fast-paced environment
- Proficient in cross collaboration with other functions such as Biostatistics, Statistical Programming, Pharmacovigilance and Clinical Operations
- Excellent written and verbal communication skills are required
- Experience and understanding of ICH, GCP and CDASH/CDISC are required
- Experience with Medidata Rave preferred
- Experience with elluminate, or comparable analytics software preferred
- Familiar with MedDRA and WHODrug coding
- Experience participating in regulatory submissions and inspections a plus
- Willing to travel on occasion
- Bay Area local candidates will only be considered for this role
- Diversity, Equity, Inclusion, and Belonging are important to us. We believe that diversity, equity, inclusion and belonging are essential for the strength of our business and the vitality of the communities we serve. To learn more about our diversity commitment, culture and values, visit
- A stimulating and rewarding workplace includes flexible work schedules, remote opportunities and the ability to achieve a work-life balance.
- We are located in Brisbane, CA, with shuttle service from BART, CalTrain and the Ferry.
- Annexon offers a competitive base salary and equity participation, employee stock purchase plan, as well as a comprehensive health benefit package that includes medical, dental, vision, 401(k), flexible spending plans, as well as other benefits.
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Senior Manager, Clinical Data Manager - Brisbane, United States - Annexon, Inc.
Description
Senior Manager, Clinical Data ManagerWork Location
Corporate Headquarters (South San Francisco, CA) Onsite - Hybrid
Position Summary
The Senior Manager, Clinical Data Manager (CDM) will work collaboratively in a fast-paced, cross functional team environment. We are seeking a highly motivated individual to join our dynamic Data Management department. This individual will play a key role in ensuring accurate, high quality clinical trial data.
Overall responsibilities will include supporting clinical data management activities from study start-up through study closure in support of trial objectives and corporate goals.
This position will report to the Director or Associate Director CDM.Responsibilities
The anticipated starting salary range for the Senior Manager, Clinical Data Manager position is $149,000- $156,300 per year.
This position will be determined based on the candidate's education, experience, transferable skills, licenses/certifications, location, and will be reviewed on a case-by-case basis to determine the final compensation.
The starting salary does not include any other potential components of the total compensation package, including bonus, equity, employer provided benefits, and perks.
Company Summary
Annexon Biosciences is a clinical-stage biopharmaceutical company seeking to bring game-changing medicines to patients with classical complement-mediated diseases of the body, brain and eye.
The classical complement cascade is a seminal pathway within the immune system that anchors and drives a host of autoimmune, neurodegenerative and ophthalmic diseases.
Annexon is advancing a new class of complement medicines targeting the early classical cascade and all downstream pathway components that contribute to disease, while selectively preserving the beneficial immune functions of other complement pathways.
Annexon is rigorously developing a pipeline of diversified product candidates across multiple mid- to late-stage clinical trials, with clinical data anticipated throughout 2023 and beyond.
EEO Employer - Annexon highly values Diversity, Equity, Inclusion and Belonging
Annexon Biosciences is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment based on race, color, religion, national origin, age, gender, sex, ancestry, citizenship status, mental or physical disability, genetic information, sexual orientation, veteran status, or military status.
Staffing Agencies
Annexon Biosciences does not accept unsolicited agency resumes and will not pay fees to any third-party agency or firm that doesn't have a signed agreement with Annexon Biosciences.
Inquiries must be sent to with the Subject Heading:
Staffing Agency Request.
Apply
Annexon is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status.
