Senior CDA, Client Facing – Min 5+ Years Data Management Experience

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

📋 Description

• Supervise fellow Clinical Data Associates in all data management tasks for international clinical trials.

• Offer assistance and serve as a backup for the Project Data Manager when necessary.

• Stay informed about contract and scope-of-work obligations and provide timely status updates.

• Review and comply with study-specific Data Management Plans.

• Generate test data and conduct User Acceptance Testing for data entry interfaces, edit checks, listings, study roles, and SDV configurations.

• Examine discrepancy outputs and validation listings; address discrepancies and implement allowed self-evident corrections.

• Resolve and re-query addressed queries when appropriate.

• Conduct quality control checks for both paper and EDC studies.

• Manage quality control for paper studies and organize document filing.

• Engage in internal meetings, in-process evaluations, audits, and inspections.

• Maintain expertise in data management systems and procedures through ongoing training.

• Execute SAS mapping quality-control evaluations.

• Supervise, train, mentor, and evaluate the work of other Clinical Data Associates.

• Reconcile external databases and datasets with clinical database information.

• Generate data-cleaning and status reports and conduct Serious Adverse Event reconciliations.

• Collaborate with Clinical Programming, Biostatistics, and Clinical Operations teams.

• Develop ad-hoc data-cleaning reports and specifications for validated listings.

• Carry out post-migration testing.

• Participate in client and third-party meetings, ensuring precise meeting minutes are distributed.

• Review database design specifications and create or assess CRFs/eCRFs.

• Contribute to Data Validation Specifications and edit checks.

• Generate study metrics reports and assist Project Data Manager activities.

• Create Discoverer, BOXI, and J-Review reports.

• Develop, update, and assess study-specific documents and data-transfer requests.

• Evaluate queries and self-evident corrections suggested by less experienced data management personnel.

• Provide EDC training to both internal and external team members.

• Act as a Subject Matter Expert for specific platforms or processes.

• Perform quality control of the Data Management Study File during the study execution.

• Represent the department at business-development meetings when necessary.

• Conduct activities in accordance with corporate guidelines, SOPs, and work instructions.

⛳️ Requirements

• A minimum of 5+ years of prior data management experience.

• BA/BS degree in biological sciences or a related field in natural sciences/healthcare.

• Proficient English language skills.

• Prior experience in the therapeutic area of Oncology.

• Familiarity with clinical data and ICH/Good Clinical Practices.

• Competence in navigating MS Windows and utilizing MS Word, Excel, and email applications.

• Exceptional keyboard speed and accuracy.

• Understanding of medical terminology.

• Strong written and verbal communication, presentation, and interpersonal skills.

• Good organizational, planning, and time-management abilities.

• Capacity to multitask under tight deadlines while maintaining attention to detail.

• Ability to work independently and as part of a multidisciplinary team.

• Capability to take on a leadership role in data management, including effective mentoring.

• Proficient in managing relationships with sponsors and internal clients.

• Experience with data management practices and relational database management software is preferred.

• Familiarity with Oracle Clinical, Rave, or Inform systems is preferred.

• Work experience in clinical research, drug development, data management, or another healthcare environment is preferred.

• Flexibility and adaptability to changing situations.

• Accountable for adherence to relevant corporate business practices, SOPs, and work instructions.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Technical and therapeutic training available.

• Peer recognition and a comprehensive rewards program.

• Inclusive workplace culture.

• Access to extensive resources including emerging technologies, data, science, and knowledge sharing.

• Opportunities for collaboration with specialized therapeutic or functional teams.

• Exposure to various career paths and employment opportunities.