Start up and Site Contracts Specialist [C917]

Start up and Site Contracts Specialist [C917]

05 ene
Empresa reconocida

05 ene

Empresa reconocida


Job Description - Start up and Site Contracts Specialist (20008885)Job Description Start up and Site Contracts Specialist - (20008885) Description JOB SUMMARY

Administers and negotiates site contracts that support projects within

Clinical Operations on a global scale, with moderate oversight from the SSU

Country Manager. Ensures site contract

documentation is in compliance with sponsor and Company requirements. Identifies project and/or individual site

contract related problems and works with internal and external team members to

provide and implement solutions. Serves

as technical expert across all Site Contracts functions. Trains and mentors junior team members and

proactively identify ways to improve internal project operations. Establishes

strong working relationships with customer, internal project teams and sites. Ensure

all relevant documents are submitted to the Trial Master File (TMF) as per

Company SOP/Sponsor Requirements.

May participate in internal team education or process improvement


Job 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.



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


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




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




basic financial aspects of the project and the number of hours/tasks available

per contract; escalates discrepancies in a timely fashion.



and complies with Standard Operating Procedures (SOPs) and Work Instructions

(WIs) in a timely manner, keeps training records updated accordingly and

Qualification & Requirements

ensures timesheet compliance. Qualifications

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.Native or high level Portuguese speaker


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.

Primary Location: Europe - PRT-Home-BasedOther Locations: Europe - ESP-Madrid-Calle-Hernani-59, Europe - ESP-Home-Based (Barcelona), Europe - ESP-Home-Based (Madrid), Europe - PRT-Lisbon-Edificio-Mythos, Europe - ESP-Barcelona-196-PauClarisJob: Site OperationsSchedule: Full-timeTravel: NoEmployee Status: Regular

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