Senior Clinical Data Manager

Placements24; Queenstown (MD); Hybrid; USD 120,000 - 170,000; Full time

Benefits offered by this job

Competitive salary

Health insurance

Retirement planning

Annual bonuses

Remote work autonomy

Job summary

Placements24 is seeking a Senior Clinical Data Manager to join a fully remote data management team. You will oversee data management activities, create DMPs, and lead data review processes to support regulatory submissions.

The ideal candidate will have extensive experience with EDC systems (Medidata Rave, Oracle Clinical, Veeva), strong CDISC SDTM/ADaM knowledge, and excellent communication skills, enabling collaboration across regulatory affairs, biostatistics, and programming teams.

Qualifications

• Bachelor's degree in a relevant scientific or technical field (e.g., Computer Science, Statistics, Life Sciences).
• Minimum of 5 years of experience in clinical data management within pharma/biotech.
• Proven expertise in designing and managing EDC systems (Medidata Rave, Oracle Clinical, Veeva).
• Thorough understanding of clinical trial processes, data standards (CDISC SDTM/ADaM), regulatory guidelines.

Responsibilities

• Lead the design, development, and execution of DMPs for assigned clinical trials.
• Oversee setup and maintenance of EDC systems and databases.
• Develop database specifications, including edit checks and data validation rules.
• Manage data cleaning activities, including query resolution and trend analysis.
• Ensure compliance with FDA/EMA and CDISC standards.
• Collaborate with clinical ops, biostatistics, programming, regulatory teams.
• Perform QC on data management deliverables.
• Develop and implement data management SOPs and practices.
• Train and mentor junior data management staff.
• Participate in database lock and prepare data for analysis.

Skills

SQL

EDC systems

Data management

CDISC SDTM/ADaM

Regulatory knowledge

Data quality

Remote work

Communication

Education

Bachelor's degree

Tools

Medidata Rave

Oracle Clinical

Veeva

Job description

About the Role

Our client is a leading global biopharmaceutical company committed to advancing healthcare through groundbreaking research and development. We are seeking a highly experienced Senior Clinical Data Manager to join our dedicated, fully remote data management team. This critical role will be instrumental in ensuring the accuracy, completeness, and integrity of clinical trial data across multiple studies. You will be responsible for overseeing data management activities, developing data management plans, and leading data review processes to support regulatory submissions. The ideal candidate will possess a deep understanding of clinical data standards, EDC systems, and data quality best practices. This is an exceptional opportunity to contribute to impactful clinical research from anywhere, working with a talented and collaborative international team. This position is designed to be fully remote, offering maximum flexibility.

Key Responsibilities

• Lead the design, development, and execution of clinical data management plans (DMPs) for assigned clinical trials.
• Oversee the setup and maintenance of Electronic Data Capture (EDC) systems and databases.
• Develop database specifications, including edit checks, data validation rules, and data flow diagrams.
• Manage data cleaning activities, including query generation, resolution, and trend analysis.
• Ensure compliance with regulatory requirements (e.g., FDA, EMA) and industry standards (e.g., CDISC SDTM/ADaM).
• Collaborate with clinical operations, biostatistics, programming, and regulatory affairs teams.
• Perform quality control checks on data management deliverables.
• Contribute to the development and implementation of data management SOPs and working practices.
• Train and mentor junior data management staff.
• Participate in database lock activities and prepare data for statistical analysis and reporting.

Requirements

• Bachelor's degree in a relevant scientific or technical field (e.g., Computer Science, Statistics, Life Sciences).
• Minimum of 5 years of experience in clinical data management within the pharmaceutical or biotechnology industry.
• Proven expertise in designing and managing EDC systems (e.g., Medidata Rave, Oracle Clinical, Veeva).
• Thorough understanding of clinical trial processes, data standards (CDISC SDTM/ADaM), and regulatory guidelines.
• Strong proficiency in SQL and experience with database querying.
• Excellent analytical, problem-solving, and organizational skills.
• Exceptional written and verbal communication skills.
• Ability to work independently and manage multiple projects effectively in a remote setting.
• Experience with data validation and quality control procedures.
• Detail-oriented with a strong commitment to data integrity.

Benefits

• Our client offers a competitive salary, a comprehensive benefits package including health insurance, retirement planning, and potential for annual bonuses.
• We provide excellent opportunities for professional development, including access to industry training and conferences.
• This fully remote position offers significant autonomy and work-life balance, allowing you to contribute effectively from your chosen location.
• Join a forward-thinking organization making a significant impact on global health.