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Associate Director, Data Management (Remote, Us)

8+ years
$150,000 - $210,000
10 Nov. 27, 2024
Job Description
Job Type: Full Time Remote Education: Minimum of a B.S. in computer science, biosciences, medical training, or a related field. M.S./M.A. preferred. 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

Job TitleAssociate Director, Data Management
LocationRemote, U.S. (Jersey City, NJ)
CompanyMitsubishi Tanabe Pharma America, Inc. (MTPA)

About MTPA:
Mitsubishi Tanabe Pharma America, Inc. (MTPA) is a U.S. subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC) in Japan. With a legacy of over 300 years, MTPC is renowned for its contributions to groundbreaking treatments in areas such as multiple sclerosis (MS), diabetes, and amyotrophic lateral sclerosis (ALS). MTPA is expanding rapidly and remains committed to improving patient outcomes through innovative therapies, including treatments for rare diseases like RADICAVA®.

Position Overview:

The Associate Director, Data Management will oversee all data management operations for clinical development studies within MTPA’s therapeutic areas. The role involves collaboration with cross-functional teams, including Biostatistics, Clinical Operations, Safety, and Regulatory Affairs, to implement and maintain electronic data capture systems and ensure high-quality data management for clinical trials.

Responsibilities:

  • Data Management Operations: Oversee data management for MTPA clinical development programs, ensuring data quality, regulatory compliance, and efficient processes.
  • Process Development & Improvement: Develop and continuously improve strategies and processes to meet data management standards.
  • Cross-Functional Liaison: Collaborate with internal and external partners (e.g., CROs) to ensure the implementation of consistent data management standards across projects and studies.
  • Leadership & Team Management: Lead Data Management project teams, supervise staff, and provide guidance to solve data management issues.
  • Regulatory & Quality Assurance: Ensure compliance with regulatory standards and contribute to submissions to regulatory authorities.
  • Documentation & SOPs: Review and maintain data management documentation and participate in the updating of SOPs.
  • Project Coordination: Ensure efficient communication, coordination, and resource management across teams.

Qualifications:

  • Education: Minimum of a B.S. in computer science, biosciences, medical training, or a related field. M.S./M.A. preferred.
  • Experience: At least 8 years of data management experience in the pharmaceutical industry, with expertise in clinical data management systems (CDMS) and electronic data management (EDC/RDC).
  • Technical Skills: Knowledge of drug development processes, regulatory requirements, medical terminology, IT systems, and CDISC/STDM.
  • Interpersonal Skills: Strong communication and collaboration skills to work effectively in a matrix organization.

Our Value Proposition:

MTPA offers an entrepreneurial, fast-paced work environment combined with the benefits of a global pharmaceutical leader. We provide opportunities for career growth, a supportive work culture, and a competitive benefits package, including:

  • Medical and Dental Health Benefits
  • Short-term and Long-term Disability Plans
  • Company-Paid and Supplemental Life Insurance
  • Critical Illness, Accident Insurance, Legal Plan, ID Theft Protection
  • Generous PTO Policy: Starting with 24 PTO days (pro-rated based on hire date)
  • Salary Range: $150,000 - $210,000 (based on experience and qualifications)
  • Incentive Programs: Eligible for Short-Term Incentive (STI) and Long-Term Incentive (LTI) programs.

Equal Opportunity Employer:

MTPA is an equal opportunity employer, committed to diversity and inclusion. All qualified applicants will be considered for employment without regard to race, color, national origin, ancestry, sex, gender, disability, or any other classification protected by applicable laws.


This concise structure presents the key aspects of the Associate Director, Data Management role, emphasizing the responsibilities, qualifications, and benefits associated with the position at Mitsubishi Tanabe Pharma America.