Sr CRA I – Study Start Up Specialist : sponsor dedicated in Johannesburg Job at Syneos Health Clinical – in South Africa
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.
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
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.
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.
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
Travel: Yes, 50 % of the Time
Employee Status: Regular
Company: Syneos Health Clinical –
Company Location: South Africa