Senior Clinical Data Manager - San Diego, CA | Biospace
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Senior Clinical Data Manager

Dart NeuroScience LLC

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Location:
San Diego, CA
Posted Date:
5/30/2017
Position Type:
Full time
Job Code:
17-020 #801548
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Clinical Data Management,

Job Description

The Senior Clinical Data Manager (Sr. CDM) 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.

Travel Required:

Available for periodic travel (~25%) including overnight stays, when required.
Ability to drive and have a valid driver’s license.

Requirements

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 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 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.