Clin Ops Specialist | Taiwan
Syneos Health
Taiwan
7天前

Description

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.

Responsibilities

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

other countryroles

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

Department)

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)

Disclaimer :

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.

Qualifications

CORE Competency Expectations :

  • Fluent in Local Languages and business proficient in English (verbal and written) and excellent communication skills
  • Good understanding of Global, Country / Regional Clinical Research Guidelines and ability to work within these guidelines.
  • Hands on knowledge of Good Documentation Practices
  • Good IT skills (Use of MS office, use of some clinical IT applications on computer) and ability to adapt to new IT applications.
  • Strong MS Excel skills required.

  • ICH-GCP Knowledge appropriate to role
  • Excellent negotiation skills for CTCs in finance area
  • Behavioural Competency Expectations :

  • Effective time management, organizational and interpersonal skills, conflict management
  • Effective communication with external customers (e.g. sites and investigators)
  • High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment
  • Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.
  • Demonstrates commitment to Customer focus, both internally and externally.
  • Able to work independently
  • Proactive attitude to solving problems / proposing solutions
  • Experience Requirements :
  • Minimum 1 - 2 years in Clinical Research or relevant healthcare experience
  • Educational Requirements :

  • Completed job training (office management, administration, finance, health care preferred) or B.A. / B.S. (Life Science preferred) or equivalent healthcare experience
  • Regular

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