Site Contracts Specialist II

4 weeks ago

Somerset, United States Syneos Health inVentiv Health Commercial LLC Full time
Job Summary

We are seeking a highly skilled Site Contracts Specialist II to join our team at Syneos Health. As a key member of our Site Start-Up team, you will be responsible for administering all contract management processes, including coordination with relevant protocol, informed consent, institution, investigator, vendor, consultant, and customer agreement documents at a project level.

This is a challenging and rewarding role that requires strong knowledge of the clinical development process and legal and contracting parameters. If you have a passion for contracts management and a desire to work in a fast-paced environment, we encourage you to apply.

Key Responsibilities
  • Administers all contract management processes, including coordination with relevant protocol, informed consent, institution, investigator, vendor, consultant, and customer agreement documents at a project level.
  • May lead (with supervision) multi-country projects including negotiating and preparing contracts, budgets, and related documents for participation in industry-sponsored clinical trials.
  • Provides support to SSUL to agree on country template contract and budget. Produces site-specific contracts from country template. Provide support in submissions for proposed contract and budget for site.
  • Provides support in negotiating budget and contract with site via Site Contracts Service Centre and SSUL with Sponsor until resolution of issues.
  • Performs quality control and arranges execution of CTAs as well as archival of documents into repositories and capture of metadata.
  • Reviews contracts for completeness and accuracy, and ensures that corrections are appropriately made and documented.
  • Provides supports to business development and represents site contracts/Site Start-Up (SSU) at internal or customer meetings.
  • Work with Contract Managers and team members with the active project management of ongoing contract issues; performs follow-up on all outstanding contract issues.
  • Supports in generating amended contract and/or budget documents as necessary, preparing contract management documentation for projects, and streamlining the contract/proposal or internal processes; and initiates and introduces creative ideas and solutions.
  • Works within the forecasted country/site contracting timelines, ensures they are complied with and tracks milestone progress in agreed upon SSU tracking system in real time.
  • Collaborates with internal and external legal, finance, and clinical operations departments, including communicating and explaining legal and budgetary issues.
  • Facilitates the execution of contracts by company signatories.
  • Maintains contract templates and site specific files and databases.
  • Trains and mentors less experienced staff members on departmental Standard Operating Procedures (SOPs) and ensures quality of team work products. Maintains and updates training material for site contract team.
  • Acts as a communication liaison between site contracts staff and internal and external customers. Provides functional guidance and keeps internal and external teams aware of all contract statuses or pending issues. Prepares correspondence as necessary.
  • Monitors basic financial aspects of the project and the number of hours/tasks available per contract; escalates discrepancies in a timely fashion.
  • Reviews and complies with Standard Operating Procedures (SOPs) and Work Instructions (WIs) in a timely manner, keeps training records updated accordingly and ensures timesheet compliance.
Requirements
  • BA/BS degree in Business Administration, Public Administration, Public Health, related field, or equivalent combination of education and experience. Advanced degree preferred.
  • High level of contracts management experience.
  • Experience in a contract research organization or pharmaceutical industry essential.
  • Strong knowledge of the clinical development process and legal and contracting parameters.
  • Strong computer skills in Microsoft Office Suite.
  • Customer focused and ability to manage challenging priorities and to remain flexible and adaptable in stressful situations.
  • Excellent understanding of clinical trial process across Phases II-IV and ICH GCP.
  • Good understanding clinical protocols and associated study specifications.
  • Excellent understanding of clinical trial start-up processes.
  • Project management experience in a fast-paced environment.
  • Good vendor management skills.
  • Excellent written/oral communication, presentation, documentation, interpersonal skills as well as strong team-orientation.
  • Strong organizational skills with proven ability to handle multiple projects excellent communication.
  • Quality-driven in all managed activities. Strong negotiating skills. Strong problem-solving skills.
  • Ability to mentor, lead and motivate more junior staff.
  • Demonstrate an ability to provide quality feedback and guidance to peers Contribute to a training and Quality assurance plan within SSU and update SOPs/WI.
What We Offer

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.

The annual base salary for this position ranges from USD $50,760- $95,900. 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.

  • Site Installation Supervisor II

    4 weeks ago

    Somerset, New Jersey, United States BEUMER Group Full time

    Job DescriptionGeneral ResponsibilityThe Site Installation Supervisor II is a key member of the project management team, responsible for overseeing mechanical and general installation activities on-site for BEUMER system projects. This role requires a self-managing, high-energy individual who can coordinate the activities of contractors and workers, ensuring...

  • Contract Specialist

    4 weeks ago

    Somerset, New Jersey, United States Terumo Medical Corporation Full time

    Job Title: Contract SpecialistAt Terumo Medical Corporation, we are seeking a highly skilled Contract Specialist to join our team. As a Contract Specialist, you will be responsible for administering specific assigned stages of the Sales Contract Lifecycle, including drafting, reviewing, and analyzing the terms and conditions, pricing, and performance of...

  • Sr. QA Specialist

    3 months ago

    Somerset, United States On-Board Companies Full time

    On-Board Scientific is hiring a QA Specialist, Change Control/CAPA based out of the New Brunswick/Somerset, NJ area! For immediate consideration please send your resume to resumes@onboardusa.com Subject Line: Position Title and State you are located About Us: On-Board Services, Incorporated is an on-site contract service provider for a local manufacturing...

  • CRA II

    2 days ago

    Somerset, United States Syneos Health inVentiv Health Commercial LLC Full time

    Description Clinical Research Associate II 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...

  • Associate Facility Engineer II

    1 month ago

    Somerset, United States JCSI Full time

    Job Title: Associate Facility Engineer IILocation: Somerset, NJ (On-site)Employment Type: Full-TimeSeniority Level: AssociateIndustry: Pharmaceuticals, ManufacturingJob Function: Engineering, Facilities ManagementAbout Lupin PharmaceuticalsJCSI, a recruitment consulting firm is partnering with Lupin Pharmaceuticals to find an Associate Facility Engineer II...

  • Biostatistical Programmer II

    1 month ago

    Somerset, United States R&G US Full time

    Job DescriptionR&G US is a leading Contract Research Organization (CRO) providing full services for clinical trial and entire drug life cycle. As a Biostatistical Programmer II, you will be responsible for developing SAS programs for SDTM, ADaM, e-submission, and client-defined analysis datasets. You will also perform quality control of low-medium complexity...

  • Controls Engineer II

    4 weeks ago

    Somerset, New Jersey, United States BEUMER Group Full time

    Job OverviewBEUMER Group is a leading international manufacturer of intralogistics solutions, specializing in conveying, loading, palletizing, packaging, sortation, and distribution technology. As a Controls Engineer II, you will play a crucial role in designing and programming machine control systems for our sortation machines, high-speed loop sorters, and...

  • Project Controls Specialist

    4 weeks ago

    Somerset, United States IPS-Integrated Project Services, LLC Full time

    Job DescriptionAt IPS, we apply our knowledge, skills, and passion to make a difference in the lives of people, solving complex challenges related to life sciences.We are seeking a dedicated Project Engineer II to join our talented team at our office located in Somerset, New Jersey.In this role, you will be assigned to projects to review, coordinate, and...

  • Biostatistical/SAS Programmer II

    6 months ago

    Somerset, United States R&G US Full time $60,000 - $100,000

    R&G US Inc. is a CRO supporting pharmaceutical and biotech companies in the design, analysis and submission of clinical trials. You may find more information at rgpharmaus.com.As a biostatistical/SAS programmer II is responsible for the following tasks:Assist in the review and input into project requirement including but not limited to SAP, CRF, and...

  • HYBRID Contract Recruiter

    1 month ago

    Somerset, United States Jobot Full time

    Job DescriptionJob DescriptionContract to hire role/ Hybrid schedule/ $$$This Jobot Consulting Job is hosted by: Billy MewtonAre you a fit? Easy Apply now by clicking the "Apply Now" buttonand sending us your resume.Salary: $32 - $36 per hourA bit about us:We are seeking a motivated and experienced Contract Recruiter to join our talent acquisition team. This...

  • Traveling Radiology Specialist

    4 weeks ago

    Somerset, United States Synergy Medical Staffing Full time

    Synergy Medical Staffing is seeking a skilled Radiology Specialist for a contract position in a dynamic healthcare environment.Job DetailsSpecialty: RadiologyDiscipline: Allied Health ProfessionalContract Type: TravelDuration: 13 weeksHours: 40 hours per weekShift: 8 hours, eveningsAs a Radiology Specialist, you will be responsible for operating imaging...

  • Regulatory Compliance Specialist

    3 weeks ago

    Somerset, New Jersey, United States Joulé Full time

    Job Title: Sr Compliance and Regulatory SpecialistAbout the Role:As a Sr Compliance and Regulatory Specialist, you will play a critical role in ensuring the quality and compliance of our pharmaceutical products. You will be responsible for managing the supplier quality program, facilitating customer audits, and leading internal audits to ensure compliance...

  • Diagnostic Imaging Specialist

    2 weeks ago

    Somerset, United States Supplemental Health Care Full time

    Job Title: Diagnostic Imaging SpecialistSupplemental Health Care is seeking a skilled Diagnostic Imaging Specialist for a travel assignment in Somerset, Kentucky.Job Type: TravelSpecialty: Diagnostic ImagingLocation: Somerset, KentuckyDuration: 13 weeksHours: 40 hours per weekShift: 8 hoursJob DescriptionAs a Diagnostic Imaging Specialist, you will be...

  • Regulatory Compliance Specialist

    4 weeks ago

    Somerset, United States The Staffing Resource Group Inc Full time

    Job DescriptionSRG offers flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire and executive search services. Our innovative approach to identifying and qualifying talent is unique to the staffing industry, featuring a cutting-edge platform that allows us to rapidly and precisely match professionals to...

  • Project Controls Specialist

    4 weeks ago

    Somerset, United States IPS-Integrated Project Services, LLC Full time

    At IPS, we're committed to delivering exceptional project outcomes for our clients in the life sciences industry. The Project Engineer II plays a vital role in ensuring the successful delivery of projects, working closely with the Project Manager to achieve quality objectives and safety milestones.Key Responsibilities:Assist in developing and maintaining...

  • Procurement Specialist

    4 weeks ago

    Somerset, New Jersey, United States Aditi Consulting Full time

    Job Summary:Aditi Consulting is seeking a highly skilled Procurement Specialist to join our team. As a key member of our supply chain team, you will be responsible for maintaining the effectiveness of our quality system components, ensuring the timely supply of materials to support production, and resolving issues related to materials....

  • SAP Ariba Specialist

    4 weeks ago

    Somerset, New Jersey, United States Terumo Medical Corporation Full time

    SAP Ariba Specialist Job SummaryThe SAP Ariba Specialist will collaborate with business stakeholders and consultants to design, develop, deploy, and support solutions in SAP Ariba and/or S/4HANA, meeting business unit needs for sourcing, contract management, commerce automation, supplier risk, supply chain collaboration, direct and indirect procurement,...

  • Senior Compliance Specialist

    4 months ago

    Somerset, United States Planet Pharma Full time

    The Senior Regulatory and Compliance Specialist candidate must be knowledgeable in global regulations pertaining to the pharmaceutical industry (or regulated industry equivalent) and their impact on manufacturing processes and practices. The ideal candidate must be agile and have well-developed organizational, interpersonal, compliance and practical...

  • Contract Customer Service Representative

    3 months ago

    Somerset, United States Lupin Pharmaceuticals Full time

    Overview: Lupin is comprised of a fast growing, innovative and robust team of manufacturing, Research and Development and commercial divisions. Together these entities make up the generic and branded U.S. business. Lupin has a significant generic pipeline, and a branded focus on womens health. Our first Research and Development facility in the US is located...

  • Senior Project Engineer, Project Controls Expert

    4 weeks ago

    Somerset, United States IPS-Integrated Project Services, LLC Full time

    At IPS, we are seeking a skilled Senior Project Engineer, Project Controls Expert to join our team. This is a challenging role that requires a high level of expertise in project controls, including cost engineering, estimating, scheduling, and earned value management.The ideal candidate will have a strong background in engineering, project management, or...