Project Specialist / Sr Project Specialist

Syneos Health; City of Westminster; On-site; GBP 30,000 - 45,000; Full time

Job summary

A leading biopharmaceutical solutions organization in the UK is seeking a candidate to manage project files and provide administrative support to Project Leads. The role requires strong organizational skills and an Associate Degree in life sciences or a related field. The ideal candidate will possess high proficiency in MS Office and effective communication abilities. A commitment to compliance and team collaboration is vital. This position supports a passion for accelerating customer success.

Benefits

Career development opportunities

Supportive management

Recognition and rewards program

Qualifications

• Knowledge of regulatory requirements in clinical settings.
• Ability to communicate effectively with team members.
• Willingness to travel if necessary, approximately 5%.

Responsibilities

• Manage project files and study information on various databases.
• Participate in internal and external meetings, providing clear minutes.
• Maintain communication among project team and site staff.
• Support Project Leads with administrative tasks.

Skills

Strong organizational skills

Strong communication skills

Ability to manage time independently

High proficiency with MS Office

Knowledge of Good Clinical Practice

High level of competence in English

Education

Associates Degree in life sciences, Medicine, Pharmacy, or Nursing

Job description

Job Responsibilities

• Set-up, maintain and/or close out project files and study information ((e.g., regulatory documents, Trial Master File (TMF), enrollment, Adverse Events (AEs)/Serious Adverse Events (SAEs), site supplies, Institutional Review Board re-approvals, data queries) on a variety of databases and systems.
• Attends, participates, prepares and distributes meeting minutes and action items for both internal and external meetings (sponsor, trusted process, functional, investigator meetings). Follows up with team members on action items to closure.
• Maintains timely and effective communication among team members and site staff. Keeps Project Leadership and Clinical Research Associates (CRAs) fully apprised of sites and study status. May contact site staff as needed for critical information.
• Provide administrative support to Project Leads and functional leads.
• Ensure all study documents are archived based on the appropriate guidelines and policy.
• Provide support for quality assurance activities, including preparation for audits and internal review, prepare documentation and follow through to resolution on actionable issues.

Job Overview

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.

Qualifications

• Associates Degree (or equivalent) level of qualification in life sciences, Medicine, Pharmacy, Nursing or related field or equivalent combination of education and experience.
• Knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements.
• Strong organizational skills.
• Ability to manage time and work independently.
• High proficiency with full MS Office Applications.
• Strong communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade.
• Ability to travel if necessary preferred (approximately 5%).
• High level of competence in English language.

About Syneos Health

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.

• 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.