Cdms Certification Jobs in Raleigh, NC (NOW HIRING)

Description

Job Summary

As an Associate Principal Consultant in R&D Advisory, you will lead as a strategic thought leader and subject matter expert across life sciences R&D domains-including clinical development, regulatory affairs, quality, and pharmacovigilance. You will lead high-impact consulting engagements, drive innovation in methodology and delivery, and cultivate trusted client relationships.

Key Responsibilities:

• Serve as executive sponsor for R&D implementation programs.
• Define and implement implementation methodologies aligned with industry regulations and best practices.
• Lead workshops, capability assessments, and business process design.
• Develop organizational change management (OCM) and training strategies.
• Deliver client roadmaps and transformation plans.
• Own client relationships and engagement strategy.
• Present findings and recommendations to senior stakeholders.
• Guide proposal development and contribute to business development efforts.
• Maintain forward-looking offerings and contribute to internal knowledge development.
• Mentor junior consultants and foster a culture of excellence.
• Contribute to R&D internal offerings, process improvement, and operational efficiencies.
• Identify and implement opportunities for optimization.
• Support R&D business development and account activities.
• Support RFP responses and proposals.
• Support staffing for ongoing and upcoming projects.

Skills and Qualifications

Essential Requirements

• Bachelor's degree in life sciences, business, or related field.
• 10+ years of experience in R&D consulting or industry roles.
• Proven leadership in enterprise implementations and transformation initiatives.
• Effective communication, presentation, and client management skills.
• Experience developing SOPs, Work Instructions, and controlled records.
• Driven and/or key contributor to multiple enterprise implementations for technologies (e.g. Veeva Vault, Medidata), operating models (functional, R&D level), business process and document optimization.
• At least 10 years' experience in R&D-focused programs and methodologies (Clinical Operations, CDMS, RIM, Quality).
• Expert in industry standards and their application across people, process, technology & data (e.g. TMF Standard Model, Regulatory submissions, CDISC data standards).
• Experience in implementation execution, leading workstreams, and high-quality project delivery.
• Experience in performance management, monitoring team progress, and supporting development plans.
• Experience in defining and executing program contracts, change orders, resource, and budget management.
• At least 10 years' experience in designing and facilitating workshops, business process modelling, capability assessments, and future state definition.
• At least 8 years' experience in project management and/or change management.
• Strong interpersonal and communication skills.
• Excellent organizational and critical thinking skills.
• A collaborative mindset and commitment to fostering a supportive team environment.

Desired Requirements

• Professional/Life Sciences certifications (e.g. PROSCI, PMI/PMP).
• Consulting skill sets such as Six Sigma, Agile & Waterfall methodologies.
• Experience with record/data migration strategies and execution.
• Data strategy development and assessments.

The annual base salary for this position ranges from $X to $Y. The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role. In addition, some positions may include eligibility to earn commissions/bonus based on company and / or individual performance.

At Syneos Health, we are dedicated to building a diverse, inclusive and authentic workplace. If your past experience doesn't align perfectly, we encourage you to apply anyway. At times, we will consider transferable skills from previous roles. We also encourage you to join our Talent Network to stay connected to additional career opportunities.

Why Syneos Health? Here, you're a part of the big picture. You will collaborate with colleagues across clinical and commercial disciplines to guide premarket development through post-market commercial strategy. Every project is a chance to solve a new challenge, learn from your colleagues, and advance your career. The diversification and breadth of our new and existing partnerships create a multitude of career paths and employment opportunities. Join our game-changing, global company dedicated to creating better, smarter, faster ways to get biopharmaceutical therapies to patients. Experience the thrill of knowing that your everyday efforts are contributing to improving patients' lives around the world.

Work Here Matters Everywhere | How are you inspired to change lives?

Syneos Health companies are affirmative action/equal opportunity employers (Minorities/Females/Veterans/Disabled)

At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position will include a competitive compensation package, Health benefits to include Medical, Dental and Vision, Company match 401k, flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos Health complies with all applicable federal, state, and municipal paid sick time requirements.