Overview

Sr CRA I – Study Start Up Specialist : sponsor dedicated in Johannesburg Job at Syneos Health Clinical – in South Africa

Job Description

Sr CRA I – Study Start Up Specialist : sponsor dedicated in Johannesburg – (21010834)


Description

Senior Clinical Research Associate I – Study Start Up Specialist

Preferrably office based in Johannesburg

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

Vendor set up and budget negotiations and review of budgets for local laboratory, radiology or other

Experience with virtual and on site Regulatory inspections

Ability to indirectly influence investigators, vendors, external partners and country managers to address and resolve issues, with minimal support

Knowledge of local labelling requirements and experience in approval of labels for importing of products

Experience with approval for devices and import of unregistered devices

Experience with Dept of Agriculture applications would be beneficial

Submission experience (for both SAHPRA and EC) preferred experience in hematologic oncology/solid tumors with the evidence of having completing a minimum of 6 initial CTAs

Reviewed and approval of IP release/site activation packages

Skills in completing multiple high quality applications and meeting submission deadline

Ability to combine both technical and administrative aspects required by submissions

Experience in completing Material Transfer Agreements and submission and follow up and completion of export permit applications

Prioritising of various tasks including new clinical trial submissions, amendments, change in site personnel

Reviewing and updating of local Standard Operating Procedures

Updating CTMS

Strong coordination and organizational skills

Ownership of country and site budgets.

Development, negotiation and completion of Clinical Study Agreements

Development of local language materials including local language Informed Consents and translations.

Demonstrated ability to Interact with IRB/IEC and Regulatory Authority for assigned protocols

Skilled knowledge of budget and contract negotiations, local regulatory environment and submission and approval processes, and understanding of how these impact study start-up.

Qualifications

What we’re looking for

  • Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
  • Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
  • Must demonstrate good computer skills and be able to embrace new technologies
  • Excellent communication, presentation and interpersonal skills
  • Ability to manage required travel of up to 75% on a regular basis

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.

Primary Location: Europe – ZAF-Client-Based

Job: Clinical Monitoring

Schedule: Full-time

Travel: Yes, 50 % of the Time

Employee Status: Regular

About Company

Company: Syneos Health Clinical –

Company Location:  South Africa

About Syneos Health Clinical -