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Intern Cta. Barcelona. Sponsor Dedicated
hace 3 meses
Description
Intern - CTA
Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success.
We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our customers achieve their objectives.
Every day we perform better because of how we work together, as one team, each the best at what we do.
We bring a wide range of talented experts together across a wide range of business-critical services that support our business.
Every role within Corporate is vital to furthering our vision of Shortening the Distance from Lab to Life.Discover what our 29,000 employees, across 110 countries already know:
WORK HERE MATTERS EVERYWHERE
Why Syneos Health
- We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
- We are committed to our Total Self culture where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
- 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
- Perform assigned activities to start‐up of investigative sites in all phases of clinical trials and Post‐authorization studies.
- Responsible for delivery of ethics submissions and regulatory notifications.
- Review essential documents required for the submissions/notifications.
- Prepare and collect complete required documentation of new Clinical Trials and amendments to Ethics Committees.
- Prepare and collect complete required documentation and submit new Post authorization studies and amendments to Ethics Committees and Autonomic Authorities.
- Prepare, send and track necessary documentation to obtain signatures and other documents from the principal investigators.
- Follow up and obtain approvals within the established deadlines.
- Act as main contact with Ethics Committees (ECs) central and locals and Autonomic Authorities.
- Review and comply with Standard Operating Procedures (SOPs) and guidelines in a timely manner, keep training records updated accordingly and ensure timesheets compliance.
- Manage the payment of fees.
- Request and obtain approval from the Health Ministry to import/export biological samples.
- Ensure all relevant documents are submitted to the Trial Master File (TMF) as per SOP/Sponsor requirements.
- Post the study documentation on the platform designated by the sponsor.
- Ensure activities are undertaken in accordance with agreed timelines and required quality standards.
- Prepare Safety notifications.
- Support continuous improvement of quality and efficiency.
Qualifications
Get to know Syneos Health
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment.
QUALIFICATION REQUIREMENTS (please indicate if 'preferred')
High School diploma or equivalent
Good communication and interpersonal skills
Ability to embrace new technologies
_Equal Opportunities Plan__. Its objective is to achieve the principle of equality of opportunity in Syneos Health's employment practices_ _ensuring that our workforce is truly representative of each gender and that every employee is respected and is able to work under equal conditions._
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