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Initiation Clinical Site Manager II

Employer
Parexel
Location
Ukraine
Salary
Competitive
Start date
18 Oct 2019
Closing date
8 Nov 2019

View more

Discipline
Operations
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

Essential Function:
Conduct and facilitate specific start-up activities such as feasibility, site identification, pre- qualification, Site Regulatory Package (SRP) review and approval, Informed Consent (ICF) customization, IRB/IEC application preparation and submission, in accordance with relevant regulations, SOPs, and study specific procedures.

This is an office-base position and it can be located at one if our offices in Kiev or Kharkiv.

Key Accountabilities:
  • Conduct country specific feasibility and/or site pre-qualification.
  • Review and validate site identification list.
  • Collect and negotiate Confidentially Agreements (CDA) as required.
  • Organize translations per country/regulatory/client requirements.
  • Review and approve country specific and/or site specific documents or essential regulatory documents (SRP).
  • Customize, review, configure, and negotiate as required country/site specific Informed Consent Forms (ICF) and their amendments.
  • Prepare and submit IRB/IEC application and follow up until final approval received (initial submission and amendments).
  • Prepare and negotiate as required initial and/or amended CSA at a site level.
  • Resolve CSA changes requested by the site and approve any change in CSA language with support from Site Contract Leader (SCL) as required.
  • Collect internal CSA signatures.
  • Complete routine departmental administrative tasks in an accurate and timely manner (e.g. timesheets, metrics, etc.).
  • Proactively keep manager informed about work progress and any issues (including conflicting priorities and free capacity).
  • Maintain a working knowledge of and ensure compliance with applicable ICH-GCP Guidelines, international and local regulations, PAREXEL SOPs, other PAREXEL training requirements, and study specific procedures and training.
  • Ensure basic understanding of project scope, milestones, budgets, and time codes and strive for high quality, timely, and efficient delivery.
  • Update all appropriate Clinical Trial Management Systems (CTMS) as indicated per function on an ongoing basis and submit all relevant documents to central files per the Central File Maintenance Plan.
  • Escalate any site and study issues that require immediate action to the Functional Lead (FL).
  • Proactively work with other project team members to meet project goals.
  • Show commitment and perform consistent high quality work

    Qualifications

    Skills:
  • Client focused approach to work.
  • Ability to interact professionally with external customers.
  • Ability to manage multiple and varied tasks with enthusiasm.
  • Attention to detail.
  • Willingness to work in a matrix and virtual team environment and to value the importance of teamwork.
  • Strong computer skills including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic .Document Management System (EDMS), and MS- Office products such as Excel and Word.
  • Sound interpersonal, verbal, and written communication skills.
  • Sound problem solving skills.
  • Sense of urgency in completing assigned tasks.
  • Effective time management in order to meet daily metrics, team objectives, and department goals.
  • Developing ability to work across cultures.
  • Ability to influence and negotiate resolutions and outcomes with sites and IRBs/IECs.
  • Willing and able to travel locally and internationally occasionally as required.

    Education:
  • Educated to degree level (biological science, pharmacy, or other health-related discipline preferred).

    Language Skills:
  • Proficient in written and oral English, French and Dutch.

    Minimum Work Experience:
  • Previous documented relevant work experience in clinical research (Site Management experience, Start Up experience).
  • Company

    Parexel International Corporation is a leading global biopharmaceutical services organization, providing a broad range of knowledge-based contract research, consulting, and medical communications services to the worldwide pharmaceutical, biotechnology and medical device industries. Committed to providing solutions that expedite time-to-market and peak-market penetration, Parexel has developed significant expertise across the development and commercialization continuum, from drug development and regulatory consulting to clinical pharmacology, clinical trials management, medical education and reimbursement. Parexel Informatics, Inc., a subsidiary of Parexel, provides advanced technology solutions, including medical imaging, to facilitate the clinical development process.

     

    Mission: Parexel’s mission is to combine the strength of our expertise, experience and innovation to advance the worldwide success of the bio/pharmaceutical and medical device industries in preventing and curing disease.

     

    Company info
    Website
    Telephone
    +44 1895 238000
    Location
    The Quays
    101-105 Oxford Road
    Uxbridge
    Middx
    UB8 1LZ
    GB

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