Clinical Data Manager jobs in United States

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The role of the Senior Clinical Data Manager is to provide data management support to the data management department across a range of projects, sponsors and therapeutic areas. Provide expertise and manage the start up of new data management studies.

• Review of clinical protocols
• Create or review Case Report Forms for data collection and compare with the protocol to ensure consistency
• Create or review Edit Check Specification document
• Preparation of UAT documentation and perform UAT of EDC and communication of findings
• Creation of study specific documents such as Data Management Plan, Data Review Plan, eCRF Completion Guidelines, etc.
• Create or review specifications for data review listings and / or customized reports to facilitate data cleaning
• Ongoing review of data entered in EDC to ensure the data is clean for analysis
• Issue queries to clinical monitors or investigational sites as appropriate
• Resolve standard queries
• Perform medical coding
• Work with external vendors on data transfer agreements / specifications
• Ensure external data is reconciled as required
• Track queries and data cleaning activities to ensure ongoing review of data entered is completed and data is fit for analysis
• Maintain study master file documents and any other documents that are required to be audit ready
• Work in accordance with internal (or sponsor, where applicable) SOPs and procedures

• May serve as the main contact for the sponsor
• Awareness of study budget and proactive identification of scope changes
• Ensure key project milestones are delivered on time with the highest quality
• Maintain timelines and communicate risks / updates to the Data Management Project Manager
• Collaborate with cross-functional team members to ensure that the study deliverables are provided on time and with quality

• Lead internal and client study team meetings effectively
• Present study updates internally and at sponsor meetings
• Share scientific, technical and practical knowledge within the team and with colleagues
• Perform work in full compliance with applicable legislation, regulations, company policies, procedures, and training
• Build effective collaborative working relationships with internal and sponsor team members
• Seek opportunities to develop innovative ideas and sharing when appropriate
• Mentorship of more junior team members
• Contribution to development of internal training materials
• Contribution to internal process improvement initiatives

• BSc or MSc in numerical discipline (or relevant equivalent industry experience).
• At least 7 years of relevant industry experience.
• Understanding of clinical drug development process, relevant disease areas, endpoints, and different study designs
• Awareness of industry and project standards & ICH guidelines
• Excellent verbal and written communication skills
• Interpersonal/teamwork skills for effective interactions
• Self-management skills with a focus on results for timely and accurate completion of competing deliverables
• Demonstrated problem solving ability and attention to detail
• Project leadership experience
• Ability to make informed and appropriate decisions

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