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Sr Cds Project Manager

7-8 years
Not Disclosed
10 March 24, 2025
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

Senior Clinical Development Services (CDS) Project Manager 

Updated: March 19, 2025
Location: India-Asia Pacific - IND-Home-Based
Job ID: 25002226

Description:
Senior Clinical Development Services (CDS) Project Manager

Syneos Health® is a fully integrated biopharmaceutical solutions organization that accelerates customer success by translating clinical, medical affairs, and commercial insights into outcomes. Our Clinical Development model focuses on placing the customer and the patient at the center of our work.

Why Syneos Health:

  • Focus on career development and progression.

  • Supportive and engaged line management.

  • Technical and therapeutic area training with peer recognition and total rewards programs.

  • Dedicated to creating an inclusive culture that promotes diversity of thought, background, and perspective.

Job Responsibilities:

  • Act as the primary liaison between the Company and the Customer to ensure project launch, conduct, and closeout according to contractual agreements.

  • Ensure projects meet internal and Customer quality standards, SOPs, GCPs, and ICH guidelines while adhering to federal and local regulations.

  • Lead and oversee the CDS project team, facilitating team building and communication.

  • Serve as a liaison between departments for project-related tasks and issues, ensuring project requirements are met.

  • Manage multiple projects, including full scope and global projects, with minimal supervision.

  • Handle operational and financial management tasks, ensuring timely identification and resolution of project risks and escalations.

  • Monitor and manage project budgets, ensuring timely notification of out-of-scope items to customers.

  • Maintain effective communication with Customers and project teams through written and verbal updates, status reports, and progress summaries.

  • Prepare information for internal review meetings and manage actions to ensure project delivery.

  • Track and evaluate project progress using various tracking and analysis tools.

  • Develop proposals and work with Business Development and Proposal/Contracts groups to define budgets and scope of work.

Qualifications:

  • Bachelor’s degree in life sciences, communications, nursing, or equivalent education and experience.

  • 7 to 8 years of project management experience in a CRO, pharmaceutical, or biotechnology company preferred.

  • Experience managing and leading clinical research projects across CDS functional areas.

  • Strong understanding of budget management and revenue recognition.

  • Experience in CRO and CDS management preferred.

  • Thorough knowledge of major Health Authority (HA) regulations (e.g., FDA, EMEA, PMDA), drug development, and project management procedures.

  • Demonstrated proficiency in ICH/GCP guidelines.

  • Strong presentation, documentation, and interpersonal skills, emphasizing proactive leadership.

  • Proficiency in Word, Excel, PowerPoint, MS Project, email, and internet.

  • Ability to handle multiple tasks and meet deadlines while maintaining high-quality work in a dynamic environment.

  • High-level proficiency in English.

  • Ability to travel up to 25%.

About Syneos Health:
In the past 5 years, we have collaborated on 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products, and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

Additional Information:
Tasks, duties, and responsibilities outlined in this job description are not exhaustive. The Company may assign other tasks or modify the job description without prior notice. Qualifications and equivalent experience will be assessed based on the Company’s discretion.

Compliance:
Syneos Health is committed to compliance with the Americans with Disabilities Act, including reasonable accommodations to assist employees or applicants in performing essential job functions.