Syneos Health

(Sr) SSU & Regulatory Specialist (Poland) - Sponsor-dedicated

Location
Client-Based, POL
Salary
Competitive
Posted
22 Apr 2021
Closes
22 May 2021
Ref
21005001
Discipline
Clinical Research
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
Sr Site Start-Up & Regulatory Specialist

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

• Independently manages multiple country, study and site level deliverables during start-up and maintenance both within Client and external business partners and vendors, when required.
• Plans and develops strategy for start-up activities to ensure successful recruitment and delivery to trial milestones
• Prepare Investigator Sites to conduct clinical trials through the review and approval of essential clinical trial and regulatory documents
• Support local regulatory in preparing and performing submissions for Health Authorities including follow up until approval. This includes substantial amendments and any other documentation requiring HA submission.
• Prepare and perform submissions for Ethics Committees including follow up until approval (protocol, amendments/IB and any other documents requiring EC submission).
• Collaborates with other internal roles in country feasibility and site selection.
• Collaborates directly with the Client internal study teams, external site staff, country ethics committees/IRB to ensure tasks and priorities are aligned to the defined study timelines
• Prepare country Informed Consent Form (ICF) and manage country ICF template
• Review and approval of Site ICFs
• Review and approval of Clinical Trial Package (CTP) documentation
• Update national registries as applicable
• Ensures that the electronic Trial Master File (eTMF) contains the relevant Clinical Trial Package (CTP) regulatory documents for site activation and ongoing study management
• When applicable, conduct drug/IMP label review & translation
• Serves as expert on country regulatory requirements and keeps up to date with evolving regulation in collaboration with Regulatory and legal
• May support the collection and distribution of documents from / to sites including obtaining insurance certificates
• May support Health Authority inspection and pre-inspection activities
• May support audit preparation & Corrective Action / Preventative Action preparation for local related issues
• Serves as an SME for key investigational sites. Documents and maintains relevant information on the site's structure, start-up processes, key contacts, etc (i.e., Site Playbook) for sharing with internal team members.
• Represents Client in local (e.g. pharma association or HA driven) working groups around start up processes in the country.What we're looking for
  • Bachelor's or Master Degree.
  • Detailed understanding of clinical trial process across Phases II-IV and ICH GCP
  • Experience in leading or participating as an active member of cross functional teams, task forces, or local and global initiatives Experience in leading or participating as an active member of cross functional teams, task forces, or local and global initiatives
  • Thorough understanding of GCP, ICH Guidelines and Country regulatory environment
  • In depth knowledge and understanding of clinical research processes, regulations and methodology
  • Demonstrated organizational and planning skills and independent decision-making ability
  • Strong organization and time management skills and ability to effectively manage multiple competing priorities
  • Ability of critical thinking and risk analysis.
  • Good verbal and written communication skills (both in English and local language).

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.

Additional Information:
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

#LI - MB1

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