Principal Specialist, Clinical Data Management

This is a fully remote position, open to applicants in Massachusetts.

📋 Description

• Lead, conduct, and manage data management tasks for assigned clinical studies and programs.

• Guide and support First-In-Human clinical studies, which includes protocol evaluation, eCRF and database design, and ensuring alignment with dose-escalation and safety goals.

• Oversee FIH data activities with swift data cleaning, near-real-time safety data assessments, and regular interim analyses.

• Collaborate with Clinical Operations, Safety, Biostatistics, Medical, DSPV, Regulatory, QC, and other internal teams.

• Review protocols, design eCRFs, coordinate user acceptance testing, document edit-check specifications, QC external data transfers, perform data quality assessments, and finalize database locks.

• Create and review policies, SOPs, processes, and related data management documents.

• Offer technical expertise and training to Data Management, Biometrics, and other departments.

• Address QA audit inquiries and findings, ensuring that Corrective Action Forms are properly resolved.

• Investigate industry trends and suggest enhancements to data management practices, procedures, and technologies.

• Develop standardized data management documents, eCRFs, and edit checks.

• Supervise the selection, validation, and implementation of data management software acquisitions and upgrades.

• Choose outsourcing vendors, evaluate proposal data management sections and scopes of work, and track budgets.

• Coordinate project and program schedules, including database locks, DSMB meetings, data review sessions, and CRO performance.

• Monitor project resources, pinpoint deficiencies, and tackle challenges with the supervisor.

• Execute quality control checks and audit procedures in accordance with department SOPs.

• Generate data review listings, issue queries, and code Medical History, adverse event, and concomitant medication data using MedDRA and WHO Drug dictionaries.

• Ensure compliance with NBI database standards, including CDISC/SDTM.

• Identify risks and communicate issues along with potential solutions.

• Engage in data management-related NDA submission activities.

• Provide performance feedback and support development plans for Data Management team members.

⛳️ Requirements

• Bachelor’s degree in computer science or a related field with 8+ years of experience in the pharmaceutical industry; or a Master’s degree with 6+ years of relevant experience; or a PhD with 4+ years of similar experience.

• Minimum of 3 years of experience in a supervisory or leadership role.

• In-depth understanding of the drug development process.

• Experience with GCP and CDISC/CDASH/SDTM standards.

• Proven experience in developing SOPs/Work Instructions and adhering to required FDA guidance documents.

• Proficient in clinical database programming, including SAS, SQL, and Medidata Rave Architect.

• Familiarity with Business Objects, Rave Targeted SDV, and Batch Uploader is preferred.

• Experience with C# programming for custom functions is a plus.

• Strong verbal and written communication skills.

• Knowledge of best practices in the functional area and familiarity with related business disciplines.

• Capability to enhance tools and processes within the functional domain.

• Ability to collaborate as part of and lead multiple teams.

• Demonstrated leadership skills, typically overseeing lower-level and/or indirect teams.

• Exceptional computer skills.

• Strong communication, problem-solving, and analytical skills.

• Ability to comprehend broader impacts across departments and divisions.

• Proven ability to meet multiple deadlines across projects and programs with precision and efficiency.

• Excellent project management skills.

🏝️ Benefits

• Annual bonus with a target of 30% of earned base salary.

• Eligibility to join an equity-based long-term incentive program.

• Retirement savings plan with company matching.

• Paid vacation.

• Paid holidays.

• Paid personal days.

• Paid caregiver/parental leave.

• Paid medical leave.

• Medical coverage.

• Prescription drug coverage.

• Dental coverage.

• Vision coverage.