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Project Data Manager (Rave)

2+ years
Not Disclosed
10 Dec. 1, 2024
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./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 (Rave)

Updated: November 28, 2024
Location: India - Asia Pacific - IND-Home-Based
Job ID: 24006187


Job Description

Overview

At Syneos Health®, we are driven to accelerate success for our customers and their patients. As a fully integrated biopharmaceutical solutions provider, we deliver innovative clinical, medical, and commercial insights tailored to modern market demands.

Our Clinical Development model prioritizes customer and patient-centric solutions while streamlining processes to foster collaboration, innovation, and excellence. With over 29,000 employees across 110 countries, we create a workplace where Work Here Matters Everywhere.


Why Syneos Health?

  • Career Development: We support your growth through professional development opportunities, therapeutic area training, and leadership coaching.

  • Inclusive Culture: Our Total Self culture celebrates authenticity and inclusivity, valuing diverse perspectives and fostering a sense of belonging.

  • Recognition and Rewards: We offer peer recognition programs and competitive total rewards packages.


Key Responsibilities

As a Project Data Manager, you will:

  • Act as the Functional Lead for Data Management, serving as the primary liaison between Data Management, Project Management, Clinical Monitoring, and other teams.

  • Coordinate and manage the assigned Data Management/Data Operations team to ensure successful delivery of project milestones.

  • Ensure all Data Management activities comply with contractual agreements, Standard Operating Procedures (SOPs), and relevant guidelines/regulations.

  • Provide project-specific training to internal and external stakeholders as needed.

  • Oversee financial aspects of assigned projects, including revenue recognition, scope changes, and collaboration with Finance and Contracts teams.

  • Monitor project progress, communicate updates, and utilize tracking tools to ensure effective data collection and query resolution.

  • Develop and maintain project plans, specifications, and documentation in accordance with SOPs and regulatory requirements.

  • Manage resources for assigned projects, ensuring availability and alignment with project needs.

  • Participate in internal and external audits and prepare necessary documentation to support audit readiness.

  • Train and mentor data management staff, fostering professional growth.

  • Contribute to proposal development and bid defense meetings.

  • Stay updated on Data Management systems and processes through regular training.

  • Perform additional tasks as assigned, with up to 25% travel required.


Qualifications

  • Education: BA/BS in biological sciences, nursing, or related fields, or equivalent experience.

  • Experience: Clinical data management experience, ideally within a Contract Research Organization (CRO). Familiarity with Oracle Clinical, Rave, or Inform systems is preferred.

  • Strong knowledge of clinical data management practices, medical terminology, and ICH-GCP guidelines.

  • Proficiency in project management methodologies and tools, with excellent organizational and time management skills.

  • Leadership experience with a demonstrated ability to guide and motivate teams.

  • Effective communication and presentation skills, both written and verbal.

  • Proficiency in MS Office applications, including Word, Excel, PowerPoint, and email platforms.

  • Flexibility to adapt to dynamic environments and work both independently and collaboratively.


Join Us

At Syneos Health, we’ve partnered with 94% of FDA-approved drugs in the past five years. Be part of a team that challenges the status quo and drives innovation in clinical research.


Apply Now

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Syneos Health is committed to creating a diverse and inclusive workplace. Even if your experience doesn’t align perfectly, we encourage you to apply, as we value transferable skills and diverse perspectives.