DirecciónDescription
Site Start-Up Local Lead
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
Accountable for execution and oversight of local operational clinical trial activities in a country for assigned protocols in compliance with ICH/GCP and country regulations, the client policies and procedures, quality standards and adverse event reporting requirements internally and externally.
Ownership of country and site budgets. Development, negotiation and completion of Clinical Trial Research Agreements (CTRA).Oversight and tracking of clinical research‐related payments. Payment reconciliation at study close‐out. Oversight of FCPA, DPS/OFAC, and maintenance of financial systems. Financial forecasting in conjunction with CRD.
Responsible for execution and oversight of clinical trial country submissions and approvals for assigned protocols. Development of local language materials including local language Informed Consents and translations. Interactions with IRB/IEC and Regulatory Authority for assigned protocols.
Responsible for managing country deliverables, timelines and results for assigned protocols to meet country commitments. Responsible for quality and compliance in assigned protocols in country. Contributes to the development of local SOPs.
Coordinates and liaises with different departments, (Finance and Legal if appropriate) to ensure country deliverables are obtained for submissions, budgets, CTRAs and local milestones. Collaborates closely with Regional Operations to align country timelines for assigned protocols. Provides support and oversight to local vendors as applicable.
Oversight and coordination of local processes. Clinical and ancillary supplies management, importing and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, and insurance process management. Enters and updates country information in clinical and finance systems.
Has ownership, oversight and impact on local regulatory and financial compliance. The position has a significant impact on how a country can deliver country‐specific trial commitments and objectives especially during study start‐up.
To assess, prioritize and drive execution of specific clinical trials in order to support and manage the pipeline and local business needs to agreed timelines and budgets. Required to in/directly influence investigators, external partners and country
operations to adhere to budget targets and agreed payment timelines.
Works in partnership internally with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and sites, IRB/IECs and Regulatory Authorities in submission and approval related‐interactions. Through continual interaction with local clinical team/s successfully delivers clinical and financial contracts within fair market value.
Qualifications
What we’re looking for
• Bachelor's Degree (or comparable) in Business Finance/ Administration/ Life Science or equivalent Health Care related experience
• 5‐7 years clinical research experience
• Requires expertise of core clinical systems, tools and metrics
• Excellent English skills required
• Strong coordination and organizational skills required
• Requires skilled knowledge of budget and contract negotiations, local regulatory environment and submission and approval processes, and understanding of how these impact study start‐up.
• Able to indirectly influence investigators, vendors, external partners and country managers to address and resolve issues, with minimal support from the CRD.
• Requires ability to make decisions independently with limited oversight from CRD. Able to manage important activities relevant to clinical research activities in the country according to predetermined global policies and commitments. Requires strong understanding of local regulatory environment for the individual to weigh pros and cons of key decisions with input from manager.
• Problem solving is essential to this position. Requires the ability to pro‐actively identify issues and risks, analyze root cause, and propose solutions to problems and escalate to management as applicable.
• Position requires extensive experience in clinical research operations and experience with project management and coordination.
• Expertise of core clinical, regulatory and financial systems, tools, metrics and local requirements is essential.
• Strong communication, leadership, and negotiation skills as well as excellent influencing and training/mentoring skills, both written and verbal, in local language and English.
• The ability to focus on multiple deliverables and protocols simultaneously is essential.
• Additionally for financial responsibilities: Background in business finance is preferred and strong knowledge and aptitude in accounting and financial procedures.
• Ability to proactively develop risk management and mitigation plans in the country and resolve issues locally.
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.
