Vendor Project Manager

Description

Vendor Project Manager
Come discover what our 25,000+ employees already know: work here matters everywhere. We're a growing and evolving biopharmaceutical industry leader, which means you'll have endless opportunities to work with experts around the world and build the career you've dreamed of.
As a part of the Syneos Health team, you'll help us deliver results for a rewarding reason - we improve patients' lives around the world. Because to us, a patient isn't just a number, they're our family, friends, and neighbors.
Why Syneos Health
• #SyneosHealthLife means we're committed to our Total Self culture - where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person's unique contributions make a difference.
• We believe our success is a direct result of the people who are driving it - you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That's why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial.
• 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 Summary
Responsible for vendor management at a project level for clinical vendors used in Clinical projects across all Therapeutic Area Business Units within Clinical Development. Interacts with project teams, sponsors, and vendors to define scope of services for vendor technologies. Responsible for directly project managing the overall implementation and ongoing oversight of one or more vendor systems for assigned projects. Oversees all vendor activities for assigned study vendors to ensure timelines and quality standards are met, including day-to-day vendor activities from start-up to close out such as timeline management, vendor contracts management, and invoicing review. Responsible for overseeing the implementation of vendor systems into production at start up and for mid-study changes.
Job responsibilities

• Subject Matter Expert on all modalities of eCOA

• Manage cross-functional team in the planning and execution of eCOA
• Familiar with eCOA technical specifications and the ability to write or assisting in the writing of specifications.
• Flexible approach to providing review and guidance on overall technical eCOA requirements
• Familiar with ePRO Scales licensing and translation actions and requirements
• Translate project experiences into standards and best practices for long-term sustainability
• Acts as a representative of the Project Vendor Management team on small to medium-sized studies, interacting with other functional groups, vendors, and sponsors, as well as coordinating activities of Clinical Vendor Technical Specialists where assigned
• May work on larger studies or programs with other Vendor Project Managers (VPMs)
• May support Bid Defense Meetings to present selected vendor technology functionality, scope, and services
• May attend internal and sponsor calls to discuss the optimal technology for projects
• Participates in workshops to develop sponsor-specific vendor technology implementation strategies
• Attends Trusted Process meetings related to clinical vendor agenda items
• Provides input to vendor technology design and data flow/strategies
• Responsible for overseeing activities performed by vendor and Project Vendor Management Technical Specialists as assigned, ensuring quality of system development and system integrations for clinical technology vendors, including developing business requirements and reviewing test scripts, monitoring of system performance in production, and ensuring completion of vendor technology UAT prior to go live
• For eCOA, in coordination with an eCOA SME, identifies forms, questionnaires, and assessments to be captured as well as translations required, identifies license and translation requirements, and obtains instrument licenses as applicable
• Responsible for coordinating clinical vendor contracts and invoicing on behalf of the project team
• Ensures tasks are completely on time and within budget according to contractual agreement and relevant Standard Operating Procedures (SOPs), guidelines, and regulations
• Obtains internal team and sponsor approval of required document(s)
• Responsible for ensuring project documentation is maintained on an ongoing basis and ensures required documentation is filed completely and accurately in the TMF
• Provides regular and timely status updates to internal and sponsor project teams regarding vendor implementation activities, including risks to delivery such as timeline delays or system-related issues and serves at central point of contact for vendor-related project issues and solicits support from CVM SMEs as required
• Works with study team, vendor, and/or support teams as needed to improve user support response and/or to reduce support issues
• Identifies risks and develops mitigation plan with support from CVM SMEs as required
• Creates device management plan when not provided by vendor, or reviews vendors plan for completeness and works with Syneos site management team members to ensure the plan is executed appropriately
• Provides feedback on performance of technology vendors at a project level
• Participates in quality improvement efforts to increase overall operational efficiency
• Coordinates process improvement and lessons learned sessions with support from CVM SMEs as needed for assigned projects and collects feedback from sponsors and project teams on vendor performance to improve future implementations
• Provides project-specific training to internal and external audiences as required
• May train and mentor internal team members for one or more clinical vendor technologies
• Participates in sponsor, internal, or agency audits and inspections as required
• Builds proficiency in clinical vendor technologies and processes through regular training and/or attendance at professional meetings/conferences

Qualifications

What we're looking for
• BA/BS preferred in the sciences, information technology or related disciplines in the natural science/health care field or equivalent combination of education and experience
• Experience working with one or more clinical technologies including at a minimum eCOA and EDC
• Experience with development of technical specifications and performing user acceptance testing
• Strong analytical, critical thinking, and problem-solving skills
• Excellent communication skills (interpersonal, written, verbal) with the ability to communicate highly technical information to all stakeholders
• Good organizational, planning, customer service, and time management skills with the ability to multitask under tight deadlines while providing attention to detail
• Ability to prioritize and manage tasks in a fast-paced, priority-shifting, and time-sensitive environment delivering high quality work
• Ability to be flexible and adapt to change
• Ability to make effective decisions and manage multiple priorities in a highly dynamic environment
• Experience working in a complex, multi-process environment is preferred
• Good project management skills
• Experience with Microsoft Office products including MS Word, MS Excel, MS PowerPoint, and MS Outlook
• Knowledge of ICH/GCP regulatory requirements for clinical studies
• Ability to communicate effectively with sponsors, vendors, and internal customers
• Responsible for performing activities that are in compliance with applicable Corporate Business Practices, Standard Operating Procedures and Working Instructions and performing other duties as assigned by management. Minimal travel may be required (up to 25%).
As a healthcare company we have an important responsibility to protect individual and public health. This position will require individuals to be fully vaccinated against COVID-19 as part of their job responsibilities, unless an exemption can be confirmed based on a medical condition or sincerely held religious belief. Submission & Approval of an Exemption does not guarantee that an exemption can be accommodated.
*This job excludes CO applicants.
Get to know Syneos Health
We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. Learn more about Syneos Health.
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.