To Discuss more about this job opportunity, please reach out to Deepak Arya (LinkedIn URL - www.linkedin.com/in/deepak-arya-8a79aa22a/), email your updated resume at Email - deepak.arya@collabera.com. Thank you!

Pay Range: $55 to $65 an hour

Industry: Pharmaceutical

Work Type: Remote

Contract Duration: 6 months (Possibility of Extension)

Job Summary:
This role supports clinical research programs by ensuring consistent application of clinical data standards from data collection through regulatory submission. The professional in this role will lead standards oversight, guide study teams, and ensure data quality and regulatory readiness. The position partners closely with clinical, statistical, and data management teams. This opportunity is ideal for a senior level expert with strong regulatory submission experience. The role operates within a large enterprise environment supporting complex clinical studies.

Key Responsibilities:

• Review electronic case report form designs to ensure alignment with CDASH and SDTM standards.
• Identify design gaps and collaborate with study teams to proactively resolve data standards issues.
• Create and review SDTM mapping and conformance specifications.
• Execute CDISC validation checks and coordinate resolution of findings with cross functional teams.
• Document unresolved validation items within appropriate reviewer guides.
• Develop and review Trial Design domains and supporting metadata.Maintain and govern CDISC metadata libraries within the metadata repository.
• Provide standards guidance and consultation for study specific data collection and mapping.
• Represent data standards within cross functional clinical and regulatory discussions.
• Communicate data standards concepts clearly to technical and non technical stakeholders.

Required Qualifications:

• Masters degree with eight years of relevant clinical research experience or bachelors degree with twelve years of experience.
• Expert knowledge of CDASH SDTM define.xml and controlled terminology.
• Proven experience mapping legacy data to SDTM for regulatory submissions.
• Minimum of two successful regulatory submissions with CDISC compliant datasets.
• Hands on experience executing CDISC validation tools.
• Strong understanding of end to end clinical data traceability.
• Experience with metadata repositories and data standards governance.

Preferred Qualifications:

• Experience supporting global regulatory submissions.
• Strong stakeholder communication and presentation skills.
• Experience consulting on complex or non standard study designs.

Benefits:

The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, (paid time , paid sick and safe time , hours of paid vacation time, weeks of paid parental leave, paid holidays annually - AS Applicable)