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Job Details

Clinical Trial Specialist II

Company: PAREXEL
Location: Uxbridge
Reference: pare-10056860
Closing Date: 12 Apr 17
Type: Permanent
Salary (£): On Application
Benefits:

Job Summary:

As the CTS II you will be required to conduct and facilitate 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 (where required), and IRB/IEC application preparation and submission, in accordance with relevant regulations, SOPs, and study specific procedures.

Requirements:

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. What if you had a partner to support you as you reach the next level in your professional path? A partner who believes a collaborative environment is key to achieving your goals? A partner who is dedicated to your health and wellness so you can help make a difference in the lives of millions worldwide?

That’s PAREXEL. We’re a diverse team of professionals focused on one goal: getting treatments into the hands of those who need them most. Working together, the results we bring to our clients and the opportunities we bring to our team get better with every step.

How can we help you on your journey? Find your path, and learn more on LinkedIn, YouTube, Facebook, Twitter, and Glassdoor.

PAREXEL strives to be the premier provider to the biopharmaceutical and medical device industries for the development and commercialization of new medical therapies worldwide. Our mission is to combine the strength of our expertise, experience and innovation to advance the worldwide success of the biopharmaceutical and medical device industries in preventing and curing disease. We believe in our values; Integrity and Ethics, Client Service and Quality, Innovation, Sense of Urgency, Open Communication, Initiative and Reward, Teamwork and Ownership.

As the CTS II you will be required to conduct and facilitate 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 (where required), and IRB/IEC application preparation and submission, in accordance with relevant regulations, SOPs, and study specific procedures.

This role is to be based at our Corporate UK Head Office in Uxbridge just near the town centre.
You will report to the Manager of Clinical Operations and work closely with all project team members as well as with Investigational Sites, Clients and any further external suppliers such as Auditors.

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 good working knowledge of, and ensure compliance with applicable ICH-GCP Guidelines, international and local regulations, PAREXELSOPs, other PAREXEL training requirements, and study specific procedures and training
- Ensure good 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 on-going 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 team members to meet project goals
- Show commitment and perform consistent high quality work
- Maintain a positive, results orientated work environment, building partnerships and modelling teamwork, communicating to the -team in an open, balanced, and objective manner
- Manage sites and protocols across multiple therapeutic areas independently
- Support less experienced staff on project assignments as appropriate
- Recognize out of scope activities and communicate to FL
- Recognize impact of issues/delays/changes on study timelines and communicate to FL
- Participate in internal audits/client meetings with support
- Require minimal supervision by Manager

Skills:
- 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 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
- 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 as required

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.
- Strong previous experience of clinical operations working in a study start up position within either the CRO or pharmaceutical industry is essential.
- Must have good previous knowledge of Study Start up tools and systems such as; Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS) would be desirable or similar systems.

In return we will be able to offer you a structured career pathway and full training within the role including awareness and understanding of the industry. Your hard work will be rewarded with a competitive salary as well as a benefits package including 25 days holiday per year, strong contributory pension scheme, life assurance, long term disability insurance, private medical cover and private dental cover as well as other leading edge benefits that you would expect with a company of this type.

 

Apply for this job: Clinical Trial Specialist 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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