Lead Clinical Data Manager at Signant Health

Where do you fit in?

As part of our team, your Key Accountabilities:

• Communicates effectively within a multi-disciplinary project team to complete assigned tasks on time and within budget.
• Collaborates across functional groups to address technical issues impacting quality/efficiency and drives technical initiatives within Data Management 
• Provides data management guidance and communicates with internal and external stakeholders on all aspects of data management activities.
• Authors and updates data management documents (DMP, DTS, CCG. etc.).
• Performs UAT on eCRFs, Reports and Edit Checks programmed to support the data review/cleaning activities specified in the DMP.
• Regularly reviews and follows up on edit checks/data monitoring outputs and verifies data extracts against the DTS, as applicable.
• Facilitates and verifies data clarifications, data corrections, and external data reconciliation with external (customer, CRA, site) and/or internal stakeholders.
• Contributes to process improvements that increase efficiency/quality, mitigate operations risks, improve team performance, and meet departmental objectives and corporate objectives.
• Assists in developing and improving Standard Operating Procedures (SOPs), Working Instructions, and Best Practices.
• Serve as a Data Management SME for Regulatory inspections/audits, Commercial activity (bid defense), and Product (new/updated product features). 

You’ll need to bring:-

• BA/BS degree in a relevant field (Medicine, Statistics, Computer Science) or equivalent work experience; Certification in CDM.
• 12+ years of professional experience in the clinical trials data management field 
• Strong communication (verbal, written) and collaboration skills across technical and non-technical cross-functional stakeholders.
• Ability to complete high quality technical documentation and to understand requirements related to system and front-end functionality, including data process flow.
• Demonstrates extreme attention to detail and organization in all aspects of work. 
• Strong ability to problem-solve, and quickly learn and apply new skills, procedures and approaches.
• Demonstrates ability to handle multiple competing priorities, meet deadlines and multi-task in an extremely fast-paced work environment with minimal direct supervision. 
• Proven ability to work both independently and in a team-oriented environment, providing support to team members & establishing/maintaining effective work relationships with co-workers within and across functional areas. 
• Demonstrates proactive and positive approach to tasks and projects overall, as well as adapting to the types of scheduling & process changes that are inherent in a fast-paced business. 
• In-depth knowledge of CDISC standards and clinical trial systems/tools such as eCOA (ePRO, eClinRO), RTSM, EDC, CTMS, CDMS.
• Knowledge of database structures or programming languages such as SAS, SQL, etc.

We would be thrilled if you bring in the below

• Familiarity with GCP and 21 CFR Part 11 is a plus 

Good people/team management skills (direct or indirect supervision)