Start-up Clinical Site Manager - Denmark

An excellent start-up Clinical Site Manager job opportunity has arisen with a leading global contract research organisation at the forefront of drug development. The company boast an excellent working environment, challenging training and development programmes and exciting projects to work on. This role is a permanent position based in Copenhagen.

The focus of this role is 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 Ethics Committee application preparation and submission, in accordance with relevant regulations, SOPs, and study specific procedures.

Job Responsibilities:

• 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 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)

• Escalate any site and study issues that require immediate action to the Functional Lead (FL)

• 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

Skills and Requirements:

• Excellent 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
• 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
• Advanced problem-solving skills
• Sense of urgency in completing assigned tasks
• Excellent time management in order to meet daily metrics, team objectives and department goals
• Proven ability to work across cultures
• Excellent ability to work independently but seek guidance when necessary
• Excellent ability to influence and negotiate resolutions and outcomes with sites and IRBs/IECs
• Willing and able to travel locally and internationally occasionally as required
• Educated to degree level (biological science, pharmacy nursing or other health-related discipline)
• Excellent written and oral English and fluent in Danish
• Substantial previous clinical trial study start-up experience or equivalent experience in clinical research with strong understanding of clinical trials methodology and terminology.
  

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Theodora Savlovschi-Wicks on +44 203 7520 314 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.