Assoc Dir, Project Vendor Management- US based

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.

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

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.

• 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

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%).

AtSyneos 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 include Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and 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 complies with all applicable federal, state, and municipal paid sick time requirements.

The annual base salary for this position ranges from $97,300 to $170,300. 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.

Disclaimer:

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.

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 may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and 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 complies with all applicable federal, state, and municipal paid sick time requirements.

Salary Range:

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.

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.