Senior Project Specialist (Sponsor Dedicated) UK, Spain, NL

Syneos Health, Inc.; United Kingdom; Hybrid; GBP 40,000 - GBP 60,000; Full time

Job summary

A leading biopharmaceutical organization is seeking a Senior Project Specialist to support clinical trials from a remote location in the UK. Responsibilities include maintaining project files, effective communication with team members, and ensuring compliance with GCP guidelines. The ideal candidate will have an Associate's Degree in life sciences, strong organizational skills, and proficiency in MS Office. Join this innovative team dedicated to improving patient outcomes worldwide.

Benefits

Career development opportunities

Supportive management

Total rewards program

Qualifications

• Associates Degree (or equivalent) level of qualification in life sciences or related field.
• Knowledge of Good Clinical Practice/ICH guidelines.
• Ability to manage time and work independently.
• Strong communication skills, both written and spoken.

Responsibilities

• Set-up and maintain project files and study information.
• Prepare and distribute meeting minutes.
• Maintain communication among team members.
• Provide administrative support to Project Leads.
• Archive all study documents as per guidelines.

Skills

Strong organizational skills

High proficiency with full MS Office Applications

Strong communication skills

Ability to manage time and work independently

Knowledge of Good Clinical Practice/ICH guidelines

Education

Associates Degree in life sciences or equivalent

Job description

Senior Project Specialist (Sponsor Dedicated) The Netherlands

Updated: Today
Location: GBR-Remote
Job ID:25104302

Description

Senior Project Specialist (Sponsor Dedicated) The Netherlands

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

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

• 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.

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

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 Syneos Health.

http://www.syneoshealth.com

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.

Summary

Roles within Clinical Project Management job family areesponsible for planning, directing, creating and communicating clinical study time-lines. Gathers input from cross-functional teams and creates plans that help the team produce deliverables on schedule. Ensures consistency of clinical study and processes across clinical trials, overseeing and resolving operational aspects of clinical trials in conjunction with project teams and in accordance with standard operating procedures (SOP), good clinical practice (GCP) and specific country regulations such as site and vendor selection, preparing clinical trial budgets. Ensures studies are conducted within clinical trial protocols, monitoring progress and following up with team members and line managers when issues develop. Implements and prepares the clinical development strategy as outlined by the clinical teams. May develop trial recruitment strategies. Impact and Contribution Individual contributors who provide organizational related support or service (administrative or clerical), as well as roles operating in support of daily business activities (e.g., technical, production, or craft levels). The majority of time is spent in the delivery of support services or activities, typically under supervision. Roles do not typically require advanced education or training. Established and experienced support individual contributor. Work consists of tasks that are typically routine, with some deviation from standard practice. Requires broad knowledge of operational systems and practices typically gained through extensive experience and/or education.

At Syneos Health, we are dedicated to building a diverse, inclusive and authentic workplace. If your pastexperience doesn’t align perfectly, we encourage you to apply anyway. At times, we take intoconsideration transferrable skills from previous roles. We also encourage you to join our Talent Network to stay connected to additional career opportunities.

Discover what our 29,000 employees already know: work here matters everywhere. We work hard,and smart, all in the name of getting much-needed therapies to thosewho need them most. A career with Syneos Health means your everyday work improvespatients’ lives around the world. Selecting us as an employer secures a career inwhich you’re guaranteed to:

Syneos Health® (Nasdaq: SYNH) is a leading integrated biopharmaceutical solutionsorganization built to accelerate customer success. We translate unique clinical,medical affairs and commercial insights into outcomes to address modern marketrealities. Together we share insights, use the latest technologies and applyadvanced business practices to speed our customers’ delivery of importanttherapies to patients. We support a diverse, equitable and inclusive culture.

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Toll-Free: 866 462 7373

Syneos Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender, gender identity, sexual orientation, protected veteran status, disability or any other legally protected status and will not be discriminated against. If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, including the use of this website, please contact us at: Email: [e-mail] One of our staff members will work with you to provide alternate means to submit your application.