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Job Details

Senior Clinical Trial Specialist (SR CTS) - Sweden

Company: PAREXEL
Location: Sweden
Reference: 39960BR
Closing Date: 13 Dec 17
Type: Permanent
Salary (£): Competitive
Benefits: Full Corproate Benefits

Job Summary:

Senior Clinical Trial Specialist / SR CTS / Sweden / Study Start Up / Start Up / Feasibility / Ethics Committee / IRAS


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.

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  Ethics Committee application preparation and submission, in accordance with relevant regulations, SOPs, and study specific procedures.

This role is to be home based in Sweden, please note that if you are based in the south of Sweden or Stockholm this would be an advantage but is not essential.

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 EC 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
- 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, PAREXELSOPs, other PAREXEL training requirements, and study specific procedures and training
- Ensure excellent 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 teammembers to meet project.
- Maintain a positive, results orientated work environment, building partnerships andmodeling teamwork, communicating to the team in an open, balanced, and objective manner
- Manage complex sites and protocols across multiple therapeutic areas with a high level of autonomy
- Provide input to country selection strategy
- Support less experienced staff on project assignments as appropriate
- Recognize out of scope activities and communicate to FL
- Anticipate impact of issues/delays/changes on study timelines and communicate to FL
- Participate in internal audits/client meetings with minimal supervision

- Excellent presentation skills
- Client focused approach to work
- Ability to interact professionallywith 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
- Ability 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 Clinical Trial Management Systems (CTMS), Electronic Document Management System (EDMS), and MS-Office products such as Excel and Word
- Excellent interpersonal, verbal, and written communication skills
- Advancedproblem solving skills
- Sense of urgency in completing assigned tasks
- Excellent time management in order to meet daily metrics, team objectives and department goals
- Provenability to work across cultures
- Excellent ability to work independently but seekguidancewhen necessary
- Excellent ability to influence and negotiate resolutions and outcomes with sites and IRBs/IECs
- Willing and able to travellocally and internationally occasionally as required

- Educated to degree level (biological science,pharmacy,or other health-relateddiscipline preferred),nursing or other relevant qualification/experience

Language Skills
- Excellent written and oral English and fluent in relevant local language

Minimum Work Experience
- Substantial previous clinical trial study start-up experience or equivalent experience in clinical research with strong understanding of clinical trials methodology and terminology.

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 holiday per year, medical Insurance, accident insurance, travel insurance,  retirement pension insurance, long term disability and more  as well as other leading edge benefits that you would expect with a company of this type

Apply for this job: Senior Clinical Trial Specialist  (SR CTS) - Sweden

Contact Information:

Address:  PAREXEL International
The Quays
101-105 Oxford Road
Tel:  +44 1895 238000
Fax:  +44 1895 238494
Website:  Visit Our Web Site

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