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About the Role

Syneos Health is a leading biopharmaceutical solutions organization focused on accelerating customer success through integrated clinical, medical affairs, and commercial insights. We are committed to simplifying our work and making Syneos Health a great place to work, fostering collaboration and innovation to accelerate therapy delivery and change lives.

Responsibilities

Collaborate with major functional areas including Business Development, Alliance Management, Contracts and Proposals Development, SSU Country Managers, Project Management, Clinical, Data Management, and Medical Writing.
Identify and evaluate fundamental issues pertaining to Site Start-Up, project regulatory pathway, and patient enrollment.
Interpret data on complex issues and make sound business decisions to ensure effective solution implementation.
Ensure all project deliverables meet internal and customer expectations, providing accurate projections, reports, and updates.
Manage ongoing risk identification, mitigation, and management.
Develop and maintain customer relationships aligned with assigned projects.
Ensure individual project targets and client needs are met with the highest quality standards, adhering to policies and procedures.
Provide oversight of all project start-up deliverables, from site selection through site activation and lifecycle maintenance.
Assume accountability for start-up deliverables including site identification, selection, regulatory activities, clinical trial agreements, investigator budgets, essential document collection, and overall SSU timelines.
Develop plans in accordance with Standard Operating Procedures and/or sponsor-scoped processes, ensuring compliance with controlled document requirements.
Develop and manage integrated site start-up timelines, reporting weekly progress and plans to address potential timing risks.
Prepare and present overall SSU strategy and status at client meetings, communicating outcomes to the project team.
Review the project SSU budget with functional leads, PM, and SSU Business Unit Controller to ensure project profitability and take corrective measures as needed.
Utilize professionally recognized tools for planning and management of scope, timeline, and resources, ensuring effective budget management.
Track and notify management of out-of-scope work requests.
Prepare core submission documents and dossiers for amendments during project lifecycle maintenance.
Perform Regulatory Impact Assessments on core amendment submission documents and communicate risk mitigation strategies.
Oversee review for Regulatory Impact Assessment to identify gaps and risks.
Assist in the development of master Subject Information Sheet (SIS) / Informed Consent Form (ICF) for amendments.
Oversee collation, quality review, and submission of country-specific applications.
Contribute to change initiatives across and within the SSU department.
Ensure all relevant documents are submitted to the Trial Master File (TMF) as per Company SOP/Sponsor requirements.
Perform other work-related duties as assigned.

Requirements

Minimal travel may be required (up to 25%).
Equivalent experience, skills, and/or education will also be considered.

Skills

Site Start-Up
Regulatory pathway
Patient enrollment
Data interpretation
Business decision-making
Risk identification
Risk mitigation
Risk management
Project deliverables
Customer relationship management
Quality standards
Policies and procedures
Site selection
Site activation
Lifecycle maintenance
Regulatory activities
Competent authorities/ethics committees
Import/export licenses
Study maintenance
Amendment submissions
Clinical trial agreements
Investigator budgets
Essential Document collection
SSU timelines
Standard Operating Procedures
Sponsor-scoped processes
Controlled document requirements
Integrated site start-up timelines
SSU strategy
SSU budget management
Project profitability
Scope management
Timeline management
Resource management
Budget management
Core submission documents
Core clinical trial application dossier
Regulatory Impact Assessment
Subject Information Sheet (SIS)
Informed Consent Form (ICF)
Country-specific applications
Change initiatives
Trial Master File (TMF)

Work Type

Full-time

About the Company

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
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.
When we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.
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. http://www.syneoshealth.com

Equal Opportunity

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.
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.