Medical Scientist (UK, 12 mo. fixed term)

Medical Scientist (UK, 12 mo. fixed term)

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.
 
Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.
 
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 deliver – for one another, our customers, and, most importantly, for those in need.
 
Discover what your 25,000 future colleagues already know:
 
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 building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life. 
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress. 

Job Responsibilities

12-month contract based in the UK

The Medical Monitor/Scientist will serve as a critical member of the clinical team, responsible for ensuring the integrity and quality of clinical data and supporting clinical oversight activities.

Key responsibilities include:

· Serving as a clinical team member assigned to data review for clinicians, including:

· Verification of subject eligibility based on medical history.

· Critical application of protocol-defined study requirements to assess data relevant to study endpoints (e.g., safety, tolerability, immunogenicity, efficacy).

· Reviewing serious and non-serious adverse events (AEs), including:

· Drafting and responding to site queries.

· Ensuring accurate and timely reconciliation of safety data.

· Reviewing reactogenicity data in eDiaries or EDC systems to ensure compliance with protocol-specified safety surveillance and monitoring.

· Assisting the lead clinician with:

· Aggregate data review and interpretation.

· Preparation and management of safety narratives.

· Slide development for internal and external presentations.

· Oversight or Participant in safety narrative authoring workflows.

· Supporting additional study-related tasks as required, such as:

· Literature reviews.

· Data cleaning.

· Review of training materials.

· Participating in safety surveillance meetings and contributing to PowerPoint creation as needed.

· Being available during normal business hours for the assigned region and working the specified number of hours per week.

· Additional responsibilities may be added based on prior experience, including study startup or conduct activities such as eDiary design, feasibility, informed consent document reviews, draft protocol reviews, safety presentations, and site interactions for safety follow up or protocol compliance and/or training.

Note: There is no interaction with regulatory authorities or direct contact with site staff in this role.

QUALIFICATIONS & SKILLS

· Medical degree (MD, DO, MBBS, or equivalent) required.

· Preferred: At least 2 years of direct patient care experience post-residency.

· Comfortable with complex medical reviews involving pediatric, adult, and obstetrical populations

· Required: Prior experience as a medical monitor, including:

· Safety data review (non-serious and serious AEs).

· Experience on an interventional clinical trial within the past 3 years (Vaccine trials preferred but not required).

· Familiarity with EDC platforms (InForm or RedCap preferred).

· Experience with J Review or a similar data review system is preferred.

· Strong ability to critically evaluate medical/scientific information.

· Understanding of clinical study design, development, and execution.

· Proficiency in Microsoft Word, PowerPoint, and Excel.

· Fluency in English (written and spoken).

· Ability to adapt to a fast-paced and evolving environment.

· Training and experience in infectious diseases and/or infection control in a hospital setting is preferred. Other relevant specialty experiences include: Family Medicine, Internal Medicine, Obstetrics and Gynecology, or Pediatrics

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.