Clinical Data Manager (Contract)
san diego, CA
We are currently searching for a skilled professional to join a well-known client’s team as a Clinical Data Manager in San Diego, California. This Clinical Data Manager will be responsible for completeness, timely delivery, and quality of clinical trial data. The ideal candidate will have advanced knowledge of clinical trial processes and be proficient in all aspects of data management. Their work will have a direct impact on not just the organization but the larger clinical industry making this an amazing career opportunity.
- Participate in vendor evaluation, qualification, and selection, as needed.
- Anticipate project requirements and institute 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 oversight of designated activities outsourced to CROs, external consultants, central and specialist labs, and other vendors.
- Perform data review for quality issues and general data trends.
- Develop or review Data Management Plans.
- Define or review Edit Check Specifications.
- Develop User Acceptance Testing (UAT) plans, coordinate, and participate in UAT.
- Review electronic case report forms (eCRFs) or paper CRFs for completeness and content, when applicable.
- Review coding and ensure coding is complete and approved by DNS Medical.
- Review or perform external data reconciliation, SAE reconciliation.
- Understand and followSOPs.Reviewand contribute to DM SOPs.
- Ensure compliance with all applicable laws, regulations, and regulatory guidelines.
- Perform other duties as assigned by management.
- Minimum 7-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 usingMedDRAand 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/ADaMdatasets.
- 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.
- 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.
- 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).