Syneos Health

Clinical Operations Lead - Single Sponsor - home based

Client-Based, GBR
07 May 2021
05 Jun 2021
Full Time
Contract Type
Experience Level
Experienced (non-manager)
Clinical Operations Lead

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.

Embedded with the Pharma client, you will be home based with some working from their London office.

The Trial Specialist is an essential role focused on executing and overseeing site conduct activities for sponsored trials, including site start-up, maintenance and close-out activities, co-monitoring, and vendor management. At this stage, the Trial Specialist is responsible for assigned trial(s) under the guidance of more senior team members.

The individual in this role is developing the core competencies of leadership, strategic thinking and planning, problem solving, and decision making. S/he is developing technical knowledge related to drug development and therapeutic area knowledge while exhibiting foundational skills in compliance, clinical trial, and project management.

Contracts and Vendor Management
• Manage site budget and contract negotiation, payment, and processing activities in collaboration with the Study Manager, Legal, and Finance
• Participate in the selection of vendors and support Study Manager in oversight of vendors across assigned trial(s); may include contract negotiation, change orders, budgeting, and meeting facilitation.

Trial Oversight
• Collaborate with medical science liaisons (MSLs) and/or regional medical directors to support sites as appropriate
• Responsible for development of site enrollment plans, start up materials, informed consent document templates (ICD), and other trial related plans (e.g. monitoring plan)
• Participate in the preparation and finalization of protocols, clinical study reports, and interim reports
• Responsible for the final review of the site level documentation and approval for initiation
• Liaise with supply chain for investigational product forecasting at the site level, including shipment and reconciliation activities
• Responsible for ensuring all supplies required for trial participation by sites are available
• Responsible for implementation of site feasibility, selection, activation, training, maintenance and close-out activities
• Responsible for implementation of trial plans for site oversight according to the monitoring plan
• Communicate with field CRAs and site staff for timely data collection and query resolution
• Oversee site documentation activities (TMF reconciliation, filing, and archiving)
• Responsible for adherence to timelines and quality at a site level for assigned trial(s).

#LI-NC1What we're looking for

• BA/BS or higher in life or health sciences preferred. Industry or relevant experience in lieu of education accepted
• Relevant experience in clinical science, clinical trial or site management, medical affairs, and/or drug development gained from a CRO or Pharmaceutical company.
• Demonstrated ability to lead and align teams in the achievement of project milestones, demonstrated capability of working in an international environment.
• Knowledge of basic clinical project financial principles
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
• Excellent communication, presentation and interpersonal skills.
• Ability to apply problem solving techniques to resolve complex issues, and apply a risk management approach to identifying and mitigating potential threats to the successful conduct of a clinical research project.

Get to know Syneos Health
We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. 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.


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