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Job Details

Clinical Trial Specialist II (CTS II) - Denmark

Company: PAREXEL
Location: Hoersholm
Reference: 39236BR
Closing Date: 13 Dec 17
Type: Permanent
Salary (£): Competitive
Benefits: Full Corproate Benefits

Job Summary:

Clinical Trial Specialist II / (CTS II) / Denmark / Copenhagen / Horsholm / Study Start up / IRAS / Ethics committee

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. We believe in our values; Integrity and Ethics, Client Service and Quality, Innovation, Sense of Urgency, Open Communication, Initiative and Reward, Teamwork and Ownership.

This role is to be based at our Danish Office situated in Horsholm.

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.

KeyAccountabilities:
Consistently meet 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 andnegotiate 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.
- 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

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 (Danish)

Minimum Work Experience:
- Previous strong experience in start-up activities for clinical trials or equivalent experience in clinical research with understanding of clinical trials methodology and terminology.
- Previous EC submission experience working in CRO or pharma industry.

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 salary and benefits package including holiday  pension scheme, health assurance,  personal accident insurance and other leading edge benefits that you would expect with a company of this type.
- 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 team members to meet project goals
- Show commitment and perform consistent high quality work.

Apply for this job: Clinical Trial Specialist II (CTS II) - Denmark

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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