Study Start Up Project Leader - Home based Italy

Syneos Health
Italy; Homeworking
Start date
7 Nov 2023
Closing date
7 Dec 2023

View more

Clinical Research, Study Start Up
Full Time
Contract Type
Experience Level
Experienced (non-manager)

Job Details


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.

Brief Description of Position:
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, policies and procedures,
quality standards and adverse event reporting requirements internally and externally.
Specific responsibilities include, but are not limited to:
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. Oversees CTCs as applicable.
Coordinates and liaises with CRM, CTC, CRA, (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.
Working closely with the CRD and local GCTO country operation 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, Skills & Experience

• 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. Specific examples of common problems include: 1) Issues in budget / CTRA negotiations,
2) Quality and compliance issues, 3) Regulatory and legal issues, and 4) issues related to functional
area deliverables that could jeopardize protocol milestones.
• 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
• 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. Requires that
the individual has ability to work effectively also in a remote virtual environment with a wide range of
• 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



Find out more about working for our company


Brief Company Description; 

Syneos Health™ (Nasdaq:SYNH) is the only fully integrated biopharmaceutical solutions organization. Our company, including a Contract Research Organization (CRO) and Contract Commercial Organization (CCO), is purpose-built to accelerate customer performance to address modern market realities. Created through the merger of two industry leading companies – INC Research and inVentiv Health – we bring together more than 23,000 clinical and commercial minds with the ability to support customers in more than 110 countries. Together we share insights, use the latest technologies and apply advanced business practices to speed our customers’ delivery of important therapies to patients. To learn more about how we are shortening the distance from lab to life® visit

Company info
Syneos Health
+1 919 844 7100
Corporate Headquarters
3201 Beechleaf Court
Suite 600
United Kingdom

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