Clinical Data Manager II, Clinical Development
Job Category:Clinical Development
Who We Are
Dart NeuroScience LLC (DNS) is a privately held company with offices in San Diego, CA.
DNS is a company discovering new technologies and developing new therapies to help maintain cognitive vitality throughout life. DNS's mission is to become the leading specialized pharmaceutical company for memory disorders by focusing on the discovery and development of innovative drugs with new mechanisms of action. These discoveries are firmly based in a careful examination of the genes involved in the reorganization of synaptic connections in the brain, a cellular/molecular process which underlies both implicit (motor skills) and explicit (facts and events) forms of memory.
Our unique company culture engages employees by promoting thought-provoking investigation and targeted research opportunities. Our collegial environment also recognizes the value of stimulating cross-functional communication and collaboration as catalysts in generating the creative spark that inspires novel approaches and produces ground-breaking results. We want to attract, retain, and reward the top talent in our field. If you are looking for a productive, meaningful career path in the area of neuroscience, we would like to hear from you!
The Clinical Data Manager II (CDM II) will provide oversight of, assist in the coordination of, and/or partake directly in the data management activities from study start-up, data processing, and database close-out in a paper or electronic environment for projects sponsored by DNS where the activities are conducted in-house or by CROs.
The ideal candidate will have advanced knowledge of clinical trial processes and be proficient in all aspects of data management from study start-up to study close-out, have experience in multiple Electronic Data Capture (EDC) environments, experience in Phase I, II, or III CNS studies, experience in the oversight of CROs and 3rd party vendors; in addition, have knowledge of implementing CDISC CDASH CRF Standards and CDISC SDTM/ADaM datasets, as well as experience in clinical trial SAS programming as related to data quality edit checks, data review, listings and reports, and tables/figures/listings (TFLs) is desired.
Duties and Responsibilities include:
- Anticipate project requirements and institute appropriate actions to ensure timelines and project goals are met.
- Responsible for completeness, timely delivery, and quality of clinical trial data.
- Participate in vendor evaluation, qualification, and selection, as needed.
- Anticipate data management project requirements, institute, and manage appropriate actions to ensure timelines and project goals are met.
- Serve as DM representative at study team meetings and as primary contact for internal departments and external vendors; provide status reports.
- Provide oversight of designated activities outsourced to CROs, external consultants, central and specialist labs, and other vendors.
- Participate in protocol design/review and CRF design/review (paper or eCRF).
- Perform data review for quality issues and general data trends.
- Develop or review Data Management Plans.
- Define or review Edit Check Specifications; test edit checks.
- Develop User Acceptance Testing (UAT) plans, coordinate, and participate in UAT.
- Develop or review CRF Completion Guidelines, Manual Review Guidelines, Data Entry Guidelines.
- Review electronic case report forms (eCRFs) or paper CRFs for completeness and content, when applicable.
- Generate, process, track and resolve queries, when applicable.
- Review coding and ensure coding is complete and approved by DNS Medical.
- Review or perform external data reconciliation, SAE reconciliation.
- Understand and follow SOPs. Review and contribute to DM SOPs.
- Ensure compliance with all applicable laws, regulations, and regulatory guidelines.
- Perform other duties as assigned by management.
- Available for periodic travel (~25%) including overnight stays, when required.
- Ability to drive and have a valid driver’s license.
- University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology
- Minimum 5-years of relevant pharmaceutical, biotech, or CRO experience in data management.
- Must be proficient in all aspects of data management from study start-up to study close.
- Knowledge of medical terminology, coding processes using MedDRA and WHO Drug, and database design and concepts.
- Working knowledge of ICH, FDA, GCP, HIPAA, GCDMP regulations and guidelines, as well as CDISC – CDASH standards, and SDTM/ADaM datasets.
- Excellent organizational skills with great attention to detail and the ability to multitask.
- Excellent verbal and written communication skills, as well as oral presentation abilities.
- Excellent interpersonal skills.
- Ability to work independently as well as collaboratively in a team environment, including liaising with multiple departments (e.g. Regulatory, Clinical Operations, Clinical Research, CMC, Pre-Clinical, Stats).
- Ability to work proactively and effectively in a fast paced, high change environment.
- Flexible; adapts to work style to meet organization needs.
- Demonstrated initiative and resourcefulness.
- Ability to mentor/train/supervise junior staff or their work.
- Ability to represent DNS in a professional manner.
- Assumes responsibility and accountability for results.
- Proficient computer skills including MS office products.
DNS offers competitive salaries and a great benefits package including paid holidays, incentive bonuses, healthcare, vision, dental, long-term disability, life insurance, flexible spending, and a 401(k) retirement savings plan. Click here to learn more.
Dart NeuroScience is an Equal Opportunity Employer/Minorities/Women/Disability/Veterans.