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Study Data Manager

1+ years
Not Disclosed
10 Oct. 17, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

About the Job

At Sanofi, our Hubs play a vital role in driving innovation, enhancing performance across departments, and serving as a launchpad for transformative work that impacts millions of lives. As a Study Data Manager within our Clinical Data Management (CDM) Group, you'll be at the forefront of this mission.

We are an innovative global healthcare company with one clear purpose: to chase the miracles of science to improve people's lives. Here, you can grow your career, explore new opportunities, and connect with inspiring colleagues. Ready to take the next step?

Major Duties and Responsibilities

  • Ensure the quality of CDM deliverables, including CRFs, CRF Completion Instructions, Centralized Monitoring Plans, Data Management Plans, Data Validation Specifications, and data review reports, guaranteeing accurate and reliable clinical study data.
  • Collaborate with internal stakeholders (Global Study Manager, Study Medical Manager, Statistician, Central Monitors, Pharmacovigilance, Quality, etc.) to coordinate CDM activities, discuss timelines, and provide updates.
  • Define and implement data cleaning and validation strategies, integrating risk-based approaches.
  • Contribute to protocol reviews, Study Risk Management Plans, SAE reconciliations, deviation reviews, and other related activities during the study.
  • Lead study activities with both internal and external CDM delivery teams, mentoring new Study Data Managers along the way.
  • Coordinate all external data activities, including specifications, loading, and reconciliation, for data collected through Central Labs, eCOA, IRT, connected devices, telemedicine, and mobile healthcare.

About You

  • Experience: Minimum of 2 years in clinical data management, with at least 1 year in a project management role.
  • Soft Skills: Strong project management capabilities, adaptability in problem-solving, and excellent interpersonal, communication, and presentation skills.
  • Technical Skills: Familiarity with clinical data management and related regulations (including ICH E6 and E8), with a risk-based mindset focused on Quality by Design (QbD).
  • Languages: Proficient in English (verbal and written) for effective communication in a global context.
  • Education: Bachelor’s degree or higher, preferably in a life sciences or drug development-related field.

Why Choose Us?

  • Bring scientific miracles to life alongside a supportive, future-focused team.
  • Discover endless opportunities to grow your talent and advance your career, whether through promotions or lateral moves, locally or internationally.
  • Enjoy a comprehensive rewards package that recognizes your contributions and amplifies your impact.
  • Take care of yourself and your family with a wide range of health and well-being benefits, including high-quality healthcare, wellness programs, and at least 14 weeks of gender-neutral parental leave.

Pursue Progress. Discover Extraordinary.

Progress happens through people from diverse backgrounds, united by a common goal: to make miracles happen. Join us in embracing change and exploring the opportunities we offer. Together, let’s pursue progress and discover extraordinary.

At Sanofi, we provide equal opportunities for all, regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity. Watch our One Day at Sanofi video and learn about our Diversity, Equity, and Inclusion initiatives at sanofi.com.