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Job Details

Clinical Trial Specialist II

Company: PAREXEL
Location: Uxbridge
Reference: 40562BR
Closing Date: 23 Dec 17
Type: Permanent
Salary (£): Competitive
Benefits: Competitive Corporate Benefits including holiday, pension, life assurance and more

Job Summary:

Study Start-Up / Uxbridge / IRAS / Clinical Trial Specialist / Ethics Committee Submissions /

Requirements:

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.

PAREXEL offers an exciting opportunity for a Study Start-Up Specialist to become part of our high performing and rapidly growing Start-Up Team in Uxbridge, as a Clinical Trial Specialist II.

As a Clinical Trial Specialist II you will 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 IEC application preparation and submission, in accordance with relevant regulations, SOPs, and study specific procedures.

This role is to be based at our UK Head Office situated in Uxbridge, this is a close distance to Uxbridge train station as well as the town centre and the building has plenty of free parking.

Key Accountabilities:
Consistently meet the requirements of a CTS I with a high degree of proficiency, accuracy, and autonomy:
- 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 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)

In addition;
- Maintain a positive, results orientated work environment, building partnerships and modeling teamwork, communicating to the team in an open, balanced, and objective manner
- Manage sites and protocols across multiple therapeutic areas independently
- 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

 

Qualifications

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

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:
- Strong previous experience in start-up activities for clinical trials or equivalent experience in clinical research with understanding of clinical trials methodology and terminology.
- You will need strong experience in study start up activities especially with a solid understanding and focus on feasibility or UK ethics submissions.

In return we will be able to offer you a structured career pathway and development within the role including awareness and understanding of the industry. Your hard work will be rewarded with a competitive base 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 and private dental cover as well as other leading edge benefits that you would expect with a company of this type.

Apply today to begin your journey!

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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