Senior Clinical Data Manager I

About the Role:

The Senior Clinical Data Manager I will complete all activities for the global clinical study data management process from start-up to database lock and regulatory submission support. This individual will aid in ensuring clean and valid clinical study data is delivered to biostatistics, through the EDC build, programming of edit checks, cleaning and performing all data management activities for the life-cycle of a study. This position will help coordinate activities with CROs, other external vendors, database programming and trial operations to define and implement data management requirements.  

Location Classification – Hybrid:

This role will be required to work onsite 2 days a week (Tuesday and Wednesday), or more depending on business needs. #LI-Hybrid

Key Responsibilities:

• Designs EDC database (form design and edit check programming) and setup at the protocol level
• Designs and development of eCRFs, CRF completion guidelines, edit checks and data management plans and manages cross-functional review
• Manages UAT for each database build and works with study team to understand the impact of all mid-study updates to the database
• Facilitates and participates in data cleaning, via patient profiles and listings, on an ongoing basis
• Issues queries and provides report trends to the internal teams and CROs
• Ensures the deliverables of external data management vendors are quality, complete and adhere to timelines while also completing reconciliation activities
• May review or complete medical coding
• Participates in reconciliation activities between the safety and clinical database on ongoing basis
• Creates data management plans and documentation as applicable
• Perform other duties and responsibilities as assigned

Qualifications:

• Education: Bachelor’s degree in life sciences or related field 
• 7+ years Clinical Data Management experience 
• Extensive years of combined Data Management/DB build and other clinical experience preferred  
• Experience with Medidata Rave (Medidata Architect) and ClinTrak 
• Medidata Architect builder proficiency with working knowledge of industry standards, such as CDISC/SDTM 
• Basic understanding of SAS, SQL and/or other clinical programming 
• Understanding of application of clinical data coding classification systems, e.g., MedDRA, WHO-Drug 
• Understanding of steps required to set up and successfully manage delivery of Phase 2-4 studies. Accompanied with strong working knowledge of GCP and ICH guidelines, and Good Clinical DM practices 
• Embody the SpringWorks Values to act with empathy and humility to drive a culture that takes ownership and accountability for their individual and teams’ performance.
• Strong interpersonal communication skills to collaborate with colleagues, stakeholders, and vendors effectively and clearly in a remote hybrid work environment.
• Ability to travel occasionally including overnight stay driven by business need.
• Relocation available. 

Compensation:

The expected salary range for this position is $114,330.00 - $150,000.00. Actual pay will be determined based on experience, qualifications, location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.