Principal Product Ops Analyst

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Description

Principal Product Ops Analyst

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

Every day we perform better because of how we work together, as one team, each the best at what we do. We bring a wide range of talented experts together across a wide range of business-critical services that support our business. Every role within Corporate is vital to furthering our vision of Shortening the Distance from Lab to Life.

Discover what our 29,000 employees, across 110 countries already know.

WORK HERE MATTERS EVERYWHERE

Why Syneos Health

• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we're able to create a place where everyone feels like they belong.
  
  

Job Responsibilities

Preferred Experience

Clinical trials research experience (CRA, Doc Management, or other roles) with hands on experience using SSU, CTMS, eTMF and/or Payments systems (Veeva Vault CTMS, Veeva Vault eTMF, Veeva Vault Payments, Veeva Vault SSU experience a plus)

OR

Minimum of two plus years providing end user operational support of a Clinical Trials Management System (CTMS), preferably Veeva Vault CTMS; or two plus years providing end user operational support of an Electronic Trial Master Files System (eTMF), preferably Veeva Vault eTMF. (Note: this must be end user business process support, not IT technical support experience)

Minimum Qualifications

• BA or BS degree
• Experience in CRO or Pharmaceutical industry
• Ability to prioritize activities effectively to accomplish individual and team goals with competing deadlines
• Ability to write and speak clearly and concisely in a variety of communication settings and styles
• Strong interpersonal skills; ability to establish and promote positive business relationships; customer service oriented
• Ability to collaborate with study staff and internal and external partners to achieve goals
• Proficient computer skills including use of MS Office Suite (Word, Excel, PowerPoint) and enterprise clinical trial management systems
• Strong organizational skills and attention to detail
• Strong problem analysis and resolution skills
• Knowledge of site management and clinical monitoring for clinical research studies
  
  

Get to know Syneos Health

Over the past 5 years, we have worked with 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.

No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

http://www.syneoshealth.com

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Summary

Work Performed

• Act as central point of contact for all modules for end users for resolution of operational, process and advanced questions about system navigation and functionality (example: data setup, site management, site monitoring, templates, filing, reporting, etc.).
• Provide business process and system expertise to support clinical project teams and functional teams regarding proper use of the systems in compliance with Syneos Health's Standard Operating Procedures (SOPs).
• Provide recommendations and offer guidance regarding issues/questions.
• Serve as subject matter expert (SME) and resource for other super users.
• Promote and facilitate efficient use of the systems.
• Meet SLAs and ad hoc project and cross project queries from trial teams and management with minimal guidance. Perform basic and advanced system administration tasks, providing direction and resolving issues related to but not limited to:
• Maintenance of Vault Clinical Global Directory in compliance with Syneos Health approved standards for Organization and Person naming.
• Maintenance, review and set up of Vault Clinical objects – Persons and Contacts, Organizations and locations
• Maintaining LOVs
• Creation of ad hoc reports
• Data fixes using Veeva provided mechanisms (Vault Loader, etc.) and minor configuration updates Job Description
• Partner with Business Support Team to ensure appropriate triage and resolution path for all technical and non-technical user issues
• Serve as escalation and central resolution point; ensuring usage and set up is in compliance with Syneos Health SOPs, Work Instructions, Training and Policies.
• Provide end users resolution for issues pertaining to system usage, navigation, and functionality – meeting established resolution targets and promoting efficient and consistent usage of Vault Clinical.
• Drive continuous improvements in support process through metrics and root cause analysis.
• Build and maintain effective working relationships with Business Support Team and end users.
• Perform other related duties incidental to the work described herein.
• Maintain Data Quality standards and conduct data quality reviews

Seniority level

• Seniority levelMid-Senior level

Employment type

• Employment typeFull-time

Job function

• Job functionProduct Management and Marketing
• IndustriesBiotechnology Research, Pharmaceutical Manufacturing, and Research Services

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