Corporate Headquarters (South San Francisco, CA) – Hybrid
Non-local candidates will be considered
The Associate Director/Sr 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 Biometrics 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 Senior Director CDM.
- Provide a high level of expertise in Data Management (DM) to support clinical studies.
- Ensure that data quality and integrity are maintained from study start through database lock.
- Lead the design of CRFs/eCRF for sound and thorough data collection through the regulatory approval process.
- Lead data review, query management, and data management metrics reporting to ensure completeness, correctness, and consistency.
- Assume data management responsibility for multiple clinical trials, including specification and testing of the Electronic Data Capture (EDC) and other data collection systems.
- Author and maintain data management documents including Data Management Plans, Data Transfer Plans, and Data Review Plans.
- Review study protocols and assist in the planning and implementation of the data management portions.
- Data Management Lead for assigned clinical studies.
- Serves as an active member of Clinical Study Teams (CST).
- Works with other functions to develop timelines and ensure that clinical data management deadlines are met.
- Oversees DM CROs as applicable.
- 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 design listings in support of clinical and medical review of data.
- Identifies and troubleshoots operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from other project team members.
- Trains other personnel on eCRFs and EDC, as needed.
- Coordinates with cross-functional team members on serious adverse event reconciliation.
- Provides feedback on draft protocols, Statistical Analysis Plans, CSRs and other documents as required.
- May participate in the development and maintenance of Standard Operating Procedures (SOPs) and Work Instructions related to data management activities.
- 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
- 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
- Residence in the bay area preferred
What Annexon offers
- 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. We continuously work to build our pipeline of underrepresented candidates for our workforce, enhance, recruit and develop a best-in-class, diverse, equitable and inclusive workforce; ensure that Black, LatinX and other underrepresented candidates have long-term sustainable opportunities to work with Annexon; and hold our vendors to the same standards under which we operate. To learn more about Annexon’s diversity commitment, culture and values, please visit https://annexonbio.com/careers/
- 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 benefit
The anticipated salary range for the Associate Director/ Sr.Manager position is $175,527 to $195,030 per year. The starting salary for 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.
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. We are proud to promote a work environment where everyone, from any background, can do their best work.
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. Please do not send agency CVs/resumes through Annexon’s website or Annexon Employees. Inquiries must be sent to email@example.com with the Subject Heading: Staffing Agency Request.