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Job Details

Initiation Clinical Site Manager II

Company: PAREXEL
Location: , Kiev,Ukraine
Reference: 40332BR
Closing Date: 22 Mar 18
Type: Not Specified
Salary (£): Competitive
Benefits:

Job Summary:

At PAREXEL, we believe that the power to work independently and intelligently should be yours every day.Your ability to understand our clients’ needs and achieve quality results is critical to our reputation as one of the best clinical research organizations (CROs) in the world. ...

Requirements:

At PAREXEL, we believe that the power to work independently and intelligently should be yours every day.
Your ability to understand our clients’ needs and achieve quality results is critical to our reputation as one of the best clinical research organizations (CROs) in the world.

An exciting and rewarding opportunity has arisen to join our international team as

Clinical Trial Associate
This role is based in our office in Kiev


to contribute to contribute to meaningful advances that benefit patients in need.

Essential role:

The Clinical Trial Associate conducts and facilitates specific start-up activities such as feasibility, site identification, pre- qualification, Site Regulatory Package (SRP) review and approval, Clinical Site Agreements (CSA) and Informed Consent (ICF) customization and negotiation, and IRB/IEC application preparation and submission, in accordance with relevant regulations, SOPs, and study specific procedures.

Key Accountabilities:

  • Conduct country specific feasibility and/or site pre-qualification
  • Review and validate site identification list
  • Collect and negotiate Confidentially Agreements (CDA)
  • 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 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 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)
QualificationsKEY QUALIFICATIONS:
  • Good presentation skills
  • Client focused approach to work
  • Ability to interact professionally with external customers.
  • Flexible attitude with respect to work assignments and new learning
  • Advanced 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 the knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS), and MS- Office products such as Excel and Word
  • Strong interpersonal, verbal, and written communication skills
  • Advanced problem solving skills
  • Sense of urgency in completing assigned tasks
  • Effective time management in order to meet daily metrics, team objectives, and department goals
  • Ability to work across cultures
  • Ability to work independently with little oversight and to proactively seek guidance when necessary
  • Strong ability to influence and negotiate resolutions and outcomes with sites
  • Willing and able to travel locally and internationally occasionally
Education
  • Educated to degree level (biological science, pharmacy or other health-related discipline preferred), nursing or other relevant qualification/experience
Language Skills
  • Proficient in written and oral English and fluent in relevant local language
Minimum Work Experience
  • Previous experience in start-up activities for clinical trials or equivalent experience in clinical research with understanding of clinical trials methodology and terminology



Starting your journey with PAREXEL comes along with an extensive induction program and ongoing training while following your individual career path. We have been recognized as a 2015 Training Top 125 by Training Magazine for our excellence in employer-sponsored training and development programs.
On your PAREXEL journey, you will be involved in all study start-up aspects of clinical trials, you will work in cross-functional teams, and with managers who know your strengths. If you’re looking for flexibility and work-life balance, we’re here to listen and help you move forward with your individual career path.
There are pivotal moments in every career: Sharing new treatments. Improving processes. Delivering life-saving advances. The people who succeed are the ones who make the journey go further and faster every time. If you’re looking to collaborate with life science industry leaders, gain exposure to industry changing technology, and find the security of a role within a global CRO join a team that will help you move forward with your individual career path.

Apply for this job: Initiation Clinical Site Manager II

Contact Information:

Address:  PAREXEL International
The Quays
101-105 Oxford Road
Uxbridge
Middlesex
UB8 1LZ
England
Tel:  +44 1895 238000
Fax:  +44 1895 238494
Website:  Visit Our Web Site
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