Job Description

Updated: Yesterday
Location: United Kingdom, United Kingdom
Job ID: 23005888-GBR

Description

Due Diligence Specialist

Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our customers achieve their objectives.

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

The Due Diligence Specialist will support Pfizer Business lines including but not limited to, Principal Investigators and Sub-Investigators for Clinical Trials, Territory Development, Targeted Investigators, Mergers and Acquisitions, Commercial Engagements, throughout the course of the relationship with Pfizer.

• Complete Due Diligence activities for respective Studies and Sites to study timelines.
• Reviews and applies skills for internal and external intelligence for Health Care Professionals in relation to performance and quality indicators
• Contributes to ensuring integrity of information supporting due diligence requirements for study participation or other Pfizer representative roles.
• Partners with local country stakeholders (Site Intelligence, CTMs, SMs, Regulatory) and/or preferred CROs, with responsibility and management of Due Diligence deliverables associated with SOPs.
• Partners with Site Intelligence Specialist and Site Activation Partner for deliverable associated with IIP Approval
• Contributes to ensuring HCPs and sites meet Pfizer requirements for study participation
• Provide Status updates on requests, queries and feedback
• Responsible for high quality and compliant and quality outputs
• Applies skills and to determine all due diligence findings and escalates as necessary for complex decisions
• Escalates, Prepares and supports DDS III as a complex contributor for disqualifying and significant findings to the Investigator Status and Due Diligence Subcommittee as required
• Coordinate local country requirements and language capabilities where required
• Ensure timely filing of documents to eTMF
• Actively participates and provides feedback for continuous quality improvement activities
• Maintains, verifies, processes, and updates PFE systems (including Registry), and documents as needed.
• Valuable contributor to the development and maintenance of the Investigator/Site Networks database.
• Able to manage a high volume of complex studies and sites
• Maintains effective relationships with other platform lines, Business Units/Research Units., and enabling lines that facilitates effective portfolio delivery

Systems & Tools

Ability to use and learn systems, and to use independently

• Ethics, National Networks and Governing Bodies Portals and platforms
• Microsoft Suite
• Clinical Trial Management Systems (CTMS)
• Electronic Trial Master File
• Shared Investigator Platform
• Centaur
• Document exchange portals
• Oracle Select
• Salesforce (Site Profile)

Qualifications

What we\'re looking for

• A scientific or technical degree in the healthcare area BS/BSc/MS/MSc is required with combination of education, training, and experience
• Minimum 2 years relevant experience in Clinical Trials, Regulatory, or ethics environment
• Experience working in the pharmaceutical industry or CRO in a similar role; experience of interaction with Regulatory agency or Ethics Committee is required
• Experience working in a global environment, working in more than 1 country is preferred
• Knowledge of clinical trial methodologies, ICH/GCP, FDA, and Global and local country regulations and requirements
• Demonstrated compliance with all applicable company, regulatory and country requirements
• Effective verbal and written communication skills in relating to colleagues and stakeholders both inside and outside of the organization
• Good technical skills and ability to learn and use multiple systems
• Must be fluent in Polish language and Hebrew.
• Multilingual capability is an asset

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 .

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 . 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.

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