Ssu Local Lead. Madrid. Sponsor Dedicated
hace 2 semanas
Description
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.
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.
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.
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.
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 negoti
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