Sr Clinical Operations Specialist (Sr CTA) - Denmark, sponsor-dedicated
- Employer
- Syneos Health
- Location
- Denmark-Client-Based, DNK
- Salary
- Competitive
- Start date
- 20 May 2021
- Closing date
- 18 Jun 2021
View more
- Discipline
- Clinical Research, Clinical Trials Manager / Administrator
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Experienced (non-manager)
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Job Details
Senior Clinical Operations Specialist - Sponsor-dedicated
Come discover what our 25,000+ employees already know: work here matters everywhere. We're a growing and evolving biopharmaceutical industry leader, which means you'll have endless opportunities to work with experts around the world and build the career you've dreamed of.
As a part of the Syneos Health team, you'll help us deliver results for a rewarding reason - we improve patients' lives around the world. Because to us, a patient isn't just a number, they're our family, friends, and neighbors.
Why Syneos Health
• #SyneosHealthLife means we're committed to our Total Self culture - where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person's unique contributions make a difference.
• We believe our success is a direct result of the people who are driving it - you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That's why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong.
Job responsibilities
• 2+ years' work experience, with 2+ years' expe-rience working in Clinical Trials
• Strong understanding of the clinical trials pro-cess and regulatory requirements
• Demonstrated proficiency in MS Office Suite (Word, Excel, PowerPoint and Access) , Outlook and MS Teams - formatting, forms creation, table of content
• Demonstrated proficiency in English grammar; ex-cellent oral and written communications skills
• Strong organizing and planning skills to work independently with efficiency and accuracy
• Ability to multi-task
• Excellent interpersonal and public relations skills
• Must be able to perform all essential functions of the position, with or without reasonable ac-commodation
Get to know Syneos Health
We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. Learn more about Syneos Health.
#LI - MB1
Come discover what our 25,000+ employees already know: work here matters everywhere. We're a growing and evolving biopharmaceutical industry leader, which means you'll have endless opportunities to work with experts around the world and build the career you've dreamed of.
As a part of the Syneos Health team, you'll help us deliver results for a rewarding reason - we improve patients' lives around the world. Because to us, a patient isn't just a number, they're our family, friends, and neighbors.
Why Syneos Health
• #SyneosHealthLife means we're committed to our Total Self culture - where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person's unique contributions make a difference.
• We believe our success is a direct result of the people who are driving it - you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That's why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong.
Job responsibilities
- Manage the Trial Master File (TMF) and ensure all essential documents are tracked and filed in a timely manner
- Ensure quality and completeness of the electron-ic TMF and Clinical Vault (CTMS Module)
- Ensure essential documents meet technical re-quirements for electronic submission
- Drive the Investigator Trial File creation pro-cess to ensure timely delivery at trial sites and coordinate printing tasks with printer ven-dor e.g. Investigator Brochures (IBs), protocols and other study related documentation
- Communicate with sites regarding trial start-up, conduct, and close-out activities
- Archive study related documents at the conclu-sion of the clinical trial within agreed time-lines
- Manage study related supplies such as advertis-ing materials, cooler bags and temperature log-gers
- Coordinate photocopying of Investigator Bro-chures (IBs), protocols and other study related documentation
- Communicate with the study site personnel and study team members as appropriate and maintain a good rapport with each
- Ensure understanding of appropriate company SOPs, ICH-GCP guidelines
- Execute other duties as may be required by the Head of Clinical Operations and other members of company Management team as training and experience allow
- Complete all company-based and job-related training as assigned by company within the required timeline.
What we're looking for
• 2+ years' work experience, with 2+ years' expe-rience working in Clinical Trials
• Strong understanding of the clinical trials pro-cess and regulatory requirements
• Demonstrated proficiency in MS Office Suite (Word, Excel, PowerPoint and Access) , Outlook and MS Teams - formatting, forms creation, table of content
• Demonstrated proficiency in English grammar; ex-cellent oral and written communications skills
• Strong organizing and planning skills to work independently with efficiency and accuracy
• Ability to multi-task
• Excellent interpersonal and public relations skills
• Must be able to perform all essential functions of the position, with or without reasonable ac-commodation
Get to know Syneos Health
We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. Learn more about Syneos Health.
#LI - MB1
• 2+ years' work experience, with 2+ years' expe-rience working in Clinical Trials
• Strong understanding of the clinical trials pro-cess and regulatory requirements
• Demonstrated proficiency in MS Office Suite (Word, Excel, PowerPoint and Access) , Outlook and MS Teams - formatting, forms creation, table of content
• Demonstrated proficiency in English grammar; ex-cellent oral and written communications skills
• Strong organizing and planning skills to work independently with efficiency and accuracy
• Ability to multi-task
• Excellent interpersonal and public relations skills
• Must be able to perform all essential functions of the position, with or without reasonable ac-commodation
Get to know Syneos Health
We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. Learn more about Syneos Health.
#LI - MB1
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