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Project Data Manager (Das)

8+ years
Not Disclosed
10 Nov. 29, 2024
Job Description
Job Type: Full Time Education: BA/BS 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

Project Data Manager (DAS) - Syneos Health


About Syneos Health

Syneos Health is a global leader in biopharmaceutical solutions, delivering integrated clinical development and commercialization services. With a presence in 110 countries and a proven track record of success, our mission is to accelerate therapeutic innovation while improving lives.

"Work Here Matters Everywhere."


Key Responsibilities

Data Management Leadership

  • Act as the primary Functional Lead for Data Management, liaising with cross-functional teams including Clinical Monitoring, Project Management, and Sponsors.
  • Oversee non-CRF data strategy, from protocol assessment to implementation and delivery.
  • Manage IXRS setup, including User Acceptance Testing (UAT) for patient enrollment and randomization.
  • Ensure non-CRF Vendor Transfer Agreements are developed, tested, and executed effectively.

Project Oversight and Communication

  • Ensure timely execution of all data management milestones in alignment with contractual agreements.
  • Serve as the main point of communication for non-CRF data deliverables and issues, both internally and with Sponsors.
  • Monitor project progress using status reports and tracking tools, addressing in-stream data collection and query resolution.

Documentation and Compliance

  • Develop and maintain project documentation (e.g., plans, specifications) per SOPs and guidelines.
  • Prepare for and participate in audits, ensuring timely and accurate documentation filing.
  • Maintain proficiency in Data Management systems and processes.

Team Leadership and Mentorship

  • Train and mentor data management staff, fostering a high-performing team environment.
  • Lead project resource planning and allocation.

Client and Financial Management

  • Manage project financials, including revenue recognition and scope changes.
  • Support business development activities, including participation in bid defense meetings.

Qualifications

Education and Experience

  • Bachelor’s degree in biological sciences, healthcare, or a related field; Registered Nurse qualification is also acceptable.
  • Minimum 8+ years of Clinical Data Management experience, including at least 4 years of core DAS experience.
  • CRO experience is preferred.

Technical Proficiency

  • Experience with Oracle Clinical, Rave, or Inform systems.
  • Proficiency in MS Office applications (Word, Excel, PowerPoint, Outlook).
  • Strong understanding of ICH/GCP guidelines and medical terminology.

Skills and Competencies

  • Exceptional project management and organizational skills, with the ability to multitask under tight deadlines.
  • Proven leadership skills with a focus on team development and cross-functional collaboration.
  • Excellent communication and presentation skills.
  • Ability to make effective decisions in dynamic environments.

Why Syneos Health?

Professional Growth

  • Career advancement opportunities, training programs, and peer recognition initiatives.

Inclusive Environment

  • A Total Self culture that embraces diversity, authenticity, and belonging.

Industry Impact

  • Contribute to groundbreaking therapies with 94% of FDA-approved drugs over the past five years.

Application Details

Transform your passion into impact. Apply Now to join a globally recognized leader in biopharmaceutical solutions. Not ready to apply? Join our Talent Network to stay informed about future opportunities.

Be part of the change. Work here matters everywhere.