About the Role
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
JOB SUMMARY
Responsible for overseeing vendor management support for clinical vendors used in Clinical projects across assigned Therapeutic Area Business Unit(s) (TBU) within Clinical Development as well as supervisory responsibilities for Project Vendor Management team members.
Responsible for supporting multiple project teams within assigned TBU(s) to resolve clinical vendor issues, working with project teams, sponsors, and clinical vendors to address identified timeline and quality concerns. Coordinates with project managers for identified projects and vendors to support issue resolution. Serves as an escalation point for project issues where a Vendor Project Manager (VPM) has not been allocated. Serves as a vendor relationship owner for one or more clinical vendors. Leads efforts for and/or works closely with other vendor relationship owners as needed on large-scale technical issues, vendor relationship issues, and supporting new business development. Serves as a recognized leader and expert on clinical vendor services including, but not limited to, eCOA, eConsent, eSource, and IRT. Interacts with project teams, sponsors, and vendors to review and clarify scope of services for vendor technologies. Supports project manager to resolve vendor contracts and invoicing concerns. May have supervisory responsibility for Project Vendor Management team members including PMs and Technical Specialists.
Job Responsibilities
Leads members of the Project Vendor Management team and may serve as VPM on large studies or programs with many clinical vendors interacting with other functional groups, vendors, and sponsors, as well as coordinating activities of Clinical Vendor Technical Specialists where assigned
May support project teams for assigned TBU when a VPM is not assigned
Contributes vendor capabilities expertise related to use of clinical technology vendors including but not limited to eCOA, eConsent, eSource, IRT, and others in support of proposals and other Business Development initiatives
Attends Bid Defense Meetings to present vendor technology functionality, scope, and services
Attends internal and sponsor calls to discuss the optimal technology for projects
Leads workshops to develop sponsor-specific vendor technology implementation strategies
Attends Trusted Process meetings related to clinical vendor agenda items
Where assigned as VPM, responsibilities include:
Responsible forvendor technologydesign 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, identifies forms, questionnaires, and assessments to be captured as well as translations required, identifieslicenseand translationrequirements, and obtainsinstrumentlicensesas 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 complex vendor-related project issues
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
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
Responsible for providing program-level vendor performance metrics to vendor relationship owner as required
Provides feedback on performance of technology vendors at a project and program level
Leads process improvement and lessons learned sessions 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
Trains and mentors internal team members and acts as a subject matter expert for multiple clinical vendor technologies
Leads quality improvement efforts to increase overall operational efficiency
Participates in sponsor, internal, or agency audits and inspections as required
Maintains proficiency in clinical vendor technologies and processes through regular training and/or attendance at professional meetings/conferences
May represent the Company as an industry expert in technology deployment including eCOA by attending and speaking at industry events such as seminars and professional association meetings
Requirements
Qualification Requirements
- 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 supervising project management and technical teams including providing training and mentorship
- Extensive experience working with multiple clinical technologies including at a minimum eCOA and EDC. Additional experience with eConsent, eSource, IRT, and/or DCT technologies strongly preferred.
- Experience with development of technical specifications and knowledge of user acceptance testing processes preferred
- 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
- Excellent 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
- Experience deploying process improvement and change management methodologies preferred
- Strong project management skills and knowledge of project management methodologies
- Demonstrated staff leadership 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%).
About the Company
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.
Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.