WhySyneos Health? Join a game-changingcompany that is reinventing the way therapies are developed and commercialized.Created through the merger of two industry leading companies, INC Research andinVentiv Health, we bring together more than 22,000 clinical and commercialminds to create a better, smarter, faster way to get biopharmaceuticaltherapies into the hands of patients who need them most.
Evolve in a globalcompany that is always looking for ways to work smarter and more efficiently asthe only fully integrated Biopharmaceutical Accelerator.
You'll be supportedwith comprehensive resources based on today's emerging technologies, data,science and knowledge - instead of practices from the past.
Teaming with someof the most talented professionals in the industry, you'll gain exposure andwork in a dynamic environment to over-
deliver and outperform. A career withSyneos Health means your everyday work improves patients’ lives around theworld.
include, but are not limited Trial and site administration :
oTrack (e.g. essential documents) and report (e.g. Safety Reports)
oEnsure collation and distribution of study tools and documents
oUpdate clinical trial databases (CTMS) and trackers
oClinical supply & non-clinical supply management, in collaboration with
oManage Labeling requirements and coordinate / sign translation change
Document management :
oPrepare documents and correspondence
oCollate, distribute / ship, and archive clinical documents, e.g. eTMF
oAssist with eTMF reconciliation
oExecute eTMF Quality Control Plan
oUpdate manuals / documents (e.g., patient diaries, instructions)
oDocument proper destruction of clinical supplies.
oPrepare Investigator trial file binders
oObtain translations of documents
Regulatory & Site Start-Up responsibilities : Collaborate with other country roles to :
oIn a timely manner, provide to and collect from investigators forms / lists for siteevaluation / validation, site start-up and submissions
oObtain, track and update study insurance certificates
oSupport preparation of submission package for IRB / ERC and support
regulatory agencies submissions.
oPublish study results for GCTO and RA where required per local legislation
Budgeting, Agreement and Payments :
Collaborate with finance / budgeting representatives for :
oDevelop, control, update and close-out country and site budgets (including Split site budget)
oDevelop, negotiate, approve and maintain contracts (e.g. CTRAs)
oTrack and report contract negotiations
oUpdate and maintain contract templates (in cooperation with Legal
oCalculate and execute payments (to investigators, vendors, grants)
oEnsure adherence to financial and compliance procedures
oMonitor and track adherence and disclosures,
Meeting Planning :
oOrganize meetings (create & track study memos / letters / protocols)
oSupport local investigator meetings (invitations, prepare materials, select
venue, support vendor where applicable)
Tasks, duties, and responsibilities as listed in this job description are notexhaustive. The Company, at its sole discretion and with no prior notice, mayassign other tasks, duties, and job responsibilities.
Equivalent experience,skills, and / or education will also be considered so qualifications ofincumbents may differ from those listed in the Job Description.
The Company, atits sole discretion, will determine what constitutes as equivalent to thequalifications described above. Further, nothing contained herein should beconstrued to create an employment contract.
Occasionally, requiredskills / experiences for jobs are expressed in brief terms. Any languagecontained herein is intended to fully comply with all obligations imposed bythe legislation of each country in which it operates, including theimplementation of the EU Equality Directive, in relation to the recruitment andemployment of its employees.
CORE Competency Expectations :
Strong MS Excel skills required.
Behavioural Competency Expectations :
Educational Requirements :