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
- 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
- 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.
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
ensures timesheet compliance.
QUALIFICATION & REQUIREMENTS
degree in Business Administration, Public Administration, Public Health,
related field, or equivalent combination of education and experience. Advanced degree preferred.
level of contracts management experience.
in a contract research organization or pharmaceutical industry essential.
knowledge of the clinical development process and legal and contracting
computer skills in Microsoft Office Suite.
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
- 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.
to mentor, lead and motivate more junior staff.
an ability to provide quality feedback and guidance to peers Contribute to a
training and Quality assurance plan within SSU and update SOPs/WI.
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.