[Hiring] Senior Data Manager @Penfield Search Partners

Role Description

The Senior Data Manager is responsible for all data management activities from study start-up through database lock and archiving and independently supporting the needs of the clinical study and programs of studies. The Senior Data Manager will ensure completeness, accuracy and consistency and meet the standards of quality analysis and reporting to regulatory bodies. In addition, the Senior Data Manager has an active role in continuous improvement and acts as a leader in the department as demonstrated by successful mentoring and consistent study delivery over time.

• Serves as data lead for one or more clinical trials, assuming responsibility for all data management activities, including access levels and permissions.
• Proactively drive quality and efficiency to meet timelines and milestones for data management in close collaboration with cross functional study team(s).
• Conduct oversight of data management activities internally and performed by the CROs and other 3rd party vendors (IRT, Safety, Lab, etc.) to meet company obligations and business objectives throughout study(ies) life cycle i.e. from protocol synopsis through database release and submission.
• Serve as a first point of contact for DM partners to ensure established milestones and deliverables are met with the highest degree of quality.
• Ensure the internal and external partners align and conform to data management expectations for the assigned compound and/or indication.
• Review and provide input for all DM documentation - CRF design and completion Guidelines, Data Management Plan, Data Transfer Specifications, etc.
• Oversee edit check specifications to support data collection and analysis required per protocol.
• Ensure the clinical database adheres to Clinical Data Acquisition Standards Harmonization guidelines allowing for optimal SDTM dataset programming.
• Suggest design for standard and non-standard data collection, identify any gaps in data collection, and challenge collection of unnecessary data.
• Participate in the creation of the clinical development plan, describing the clinical development strategy and possible innovative trial designs.
• Set quality expectations and timelines for data management deliverables and regularly follow up on data management milestones. Ensure inspection readiness at all times.
• Set expectations and communicate in a transparent, clear way and motivate team members to work towards achieving the clinical goals.
• Follow department and company standard operating procedures (SOPs), forms, templates and policies. Provide feedback and update these guidelines as needed.
• Develop, review, and maintain all study Data Management documentation.
• Take responsibility for and guide effective quality control (QC) review and user acceptance testing (UAT) of the clinical database prior to its release into production, including oversight of staff performing these tasks.
• Ensure data are properly reviewed in accordance with the Data Management Plan (DMP) and guidelines and that cleaning is effective and timely.
• Provide input on study timelines, identify risks, and communicate mitigation strategies to the Project Manager.
• Provide input into improving the efficiency of data management tasks.
• Lead and participate in intradepartmental or interdepartmental process and quality improvement initiatives.

Qualifications

• Bachelor's Degree in computer sciences, health-related sciences, or relevant field and 7+ years of Data Management experience.
• Proven hands-on, direct, individual contributor experience with all data management tasks as well as DM vendor oversight to meet aggressive timelines of high-quality data deliverables.
• Extensive hands-on experience with clinical data management practices within industry sponsored clinical trials.
• In depth knowledge of industry leading eCRF tools and well versed in industry trends and emerging technologies supporting data collection.
• Proficient experience using commercial clinical data management systems and/or EDC products e.g. Medidata Rave. Must have Medidata RAVE experience.
• Strong project management; exhibits expertise in metrics analysis and reporting methodologies.
• Knowledge of clinical research, FDA & ICH, GCP, GCDMP, related regulatory requirements.
• Contribute to the growth and development of the DM team.
• Excellent verbal and written communication skills.
• Professional attitude and strong interpersonal skills.
• Ability to work well with a multi-disciplinary team of professionals.
• Flexible attitude with respect to work assignments and new learning.
• Ability to prioritize workload.
• Superior attention to detail.
• Understanding of clinical research and the relationship of Data Management in the clinical study process.
• Strong technical aptitude and ability to adapt to multiple data management platforms.
• Strong knowledge of electronic data capture (EDC) clinical data management systems.
• Strong computer skills (Microsoft Office Suite, Medidata Rave) and ability to understand and adapt to various information technology (IT) systems.

Preferred Requirement(s)

• Working knowledge of R/R Shiny/Posit Connect or other similar tools for data quality review, reconciliation, and dashboards is a plus.