Sr Clinical Operations Specialist in Finance

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.  

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.

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

• Key Responsibilities:

  
  • Trial and site administration:

  o Track (e.g. essential documents) and report (e.g. Safety Reports)

  o Ensure collation and distribution of study tools and documents

  o Update clinical trial databases (CTMS) and trackers

  o Clinical supply & non-clinical supply management, in collaboration with other country roles

  o Manage Labeling requirements and coordinate/sign translation change request

  
  • Document management:

  o Prepare documents and correspondence

  o Collate, distribute/ship, and archive clinical documents, e.g. eTMF

  o Assist with eTMF reconciliation

  o Execute eTMF Quality Control Plan

  o Update manuals/documents (e.g., patient diaries, instructions)

  o Document proper destruction of clinical supplies.

  o Prepare Investigator trial file binders

  o Obtain translations of documents

  
  • Meeting Planning:

  o Organize meetings (create & track study memos/letters/protocols)

  o Support local investigator meetings (invitations, prepare materials, select venue, support vendor where applicable)

• Qualifications: 

• 
  • Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.

• 
  • Hands on knowledge of Good Documentation Practices

  
  • Good IT skills (Use of MS office, use of some clinical IT applications on computer) and ability to adapt to new IT applications. Strong MS Excel skills required.

  
  • ICH-GCP Knowledge appropriate to role

  Benefits

• Competitive remuneration package with excellent benefits
• Commitment to your development and training, with the opportunity to progress your career within a market leading and innovative organization
• Opportunity to work within a successful and rewarding environment

• 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.

  Are you interested?

  If you are interested in this role and you believe you would be the right fit, we would be more than happy to hear from you. You can apply online.

  To find out more about our company and search and apply for other open jobs please visit our website  
  
   

   #LI-ZB1

  About us:

  Why Syneos Health? Join a game-changing company that is reinventing the way therapies are developed and commercialized. Created through the merger of two industry leading companies, INC Research and inVentiv Health, we bring together more than 24,000 clinical and commercial minds to create a better, smarter, faster way to get biopharmaceutical therapies into the hands of patients who need them most. Evolve in a global company that is always looking for ways to work smarter and more efficiently as the only fully integrated Biopharmaceutical Accelerator. You'll be supported with comprehensive resources based on today's emerging technologies, data, science and knowledge - instead of practices from the past. Teaming with some of the most talented professionals in the industry, you'll gain exposure and work in a dynamic environment to over-deliver and outperform.

  Disclaimer:

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. 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.