Senior Manager, Data Management (LATAM)

2 hours, 14 minutes ago
Full-time
Lead
Project and Program Management
Precision For Medicine

Precision For Medicine

Precision for Medicine is a specialized scientific services company that helps pharmaceutical and life sciences clients innovate, develop, and commercialize next-generation medical products. With a diverse team of experts, they offer comprehensive serv...

Pharmaceuticals
1K-5K
Founded 2012
$225M raised

Description

  • Manage the day-to-day activities of the Data Management function in line with SOPs, regulatory directives, and study-specific plans.
  • Oversee the planning, implementation, and execution of contracted data management activities.
  • Lead, supervise, mentor, and develop data managers and other DM staff.
  • Coordinate inter-departmental, sponsor, vendor, and global project team communication.
  • Review RFPs, proposals, change orders, and prepare project estimates.
  • Support contractual and financial management of assigned projects.
  • Oversee data entry processes, including data entry guidelines, training, quality, and resourcing for paper studies.
  • Monitor project timelines, deliverables, quality, and budget expectations for assigned studies.
  • Develop or review CRF specifications, edit checks, database build documentation, and UAT activities as needed.
  • Support SOP development, process documentation, training creation, and cross-functional process improvement initiatives.

Requirements

  • Bachelor’s degree with direct clinical trial experience in a CRO or pharmaceutical environment.
  • Minimum of 8 years of data management experience.
  • Minimum of 3 years of line management experience.
  • Previous experience managing people in a scientific or clinical background is preferred.
  • Proficiency in Microsoft Office, including Word, Excel, PowerPoint, and Outlook.
  • Ability to handle a variety of clinical research tasks.
  • Excellent organizational and communication skills.
  • Professional written and spoken English.
  • Experience using clinical database management systems.
  • Broad knowledge of drug, device, and/or biologic development and effective data management practices.
  • Strong leadership and interpersonal skills.
  • Experience in a clinical, scientific, or healthcare discipline is preferred.
  • Experience with dictionary medical coding tools such as MedDRA and WHODrug is preferred.
  • Understanding of CDISC standards such as CDASH, SDTM, and ADaM is preferred.
  • Oncology and/or orphan drug therapeutic experience is preferred.
  • Knowledge of the clinical research process from Phase I through regulatory submission.
  • Strong knowledge of data governance, data quality, data integration, and data security principles.
  • Familiarity with data privacy and compliance regulations.
  • Project management experience leading cross-functional teams.

Benefits

  • Remote work option (#LI-REMOTE).
  • Opportunity for some domestic and international travel.
  • Equal Opportunity Employer status.
  • Reasonable accommodation support for applicants with disabilities.
  • Privacy and candidate data handling protections under the company’s Privacy Policy and CA Privacy Notice.

Interested in this position?

Apply directly on the company website

Apply Now

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