Vendor Project Manager

Incresearch (Madrid, España) Publicado hace 4 días
Remote Friendly Translation And Transcription Europe Full-time

At Syneos Health we are currently looking for a Project Vendor Manager to be based in Spain and or France. The selected candidate will be responsible for vendor management at a project or program level for Project 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 complex 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






  • Acts as a representative of the Project Vendor Management team on large studies or programs with many Project Vendors interacting with other functional groups, vendors, and sponsors, as well as coordinating activities of Project Vendor Technical Specialists where 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

  • Participates in and may lead workshops to develop sponsor-specific vendor technology implementation strategies

  • Attends Trusted Process meetings related to Project Vendor agenda items

  • Responsible for 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, 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 Project 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

  • Participates in and may lead quality improvement efforts to increase overall operational efficiency

  • 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 may act as a subject matter expert for one or more Project Vendor technologies

  • Participates in sponsor, internal, or agency audits and inspections as required

  • Maintains proficiency in Project Vendor technologies and processes through regular training and/or attendance at professional meetings/conferences



The ideal candidate should have the following qualifications:




  • 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

  • Extensive experience working with one or more clinical technologies including at a minimum eCOA and EDC. Additional experience with eConsent, eSource, IRT, and/or DCT technologies preferred.

  • 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

  • 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

  • Strong project management skills, knowledge of project management methodologies preferred

  • 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% travel)





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.

Primary Location: Europe - ESP-Home-Based (Madrid)

Other Locations: Europe - ESP-Home-Based (Barcelona), Europe - FRA-Home-Based

Job: Clinical Operations

Schedule: Full-time

Travel: No

Employee Status: Regular

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