Description

Global Clinical Lead/CTM in RWE (Clinical Scientist) - Sponsor-dedicated

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

The Clinical Scientist (CS) will provide observational study execution including epidemiological, non-interventional, pragmatic and low-interventional studies and research collaborations to ensure consistency of approach, conduct, monitoring, analysis, reporting, and oversight of core team activities within one or more asset programs in the Therapeutic Area (TA). 

In collaboration with cross functional colleagues, the CS is responsible for execution and project management of their studies as well as oversight of studies executed by CSs supporting the product.  The CS collaborates with other Sponsor groups and oversees vendors to execute the studies. 

The CS has a significant role in partnership with Medical Evidence Generation (MEG), Medical Affairs, Statistics, Clinical Data Sciences, Statistical Data Sciences & Analytics, and external team members, where applicable, and other team members on development of operational plans and provides input on tactical implementation of studies to support the asset strategies in line with Sponsor SOPs.  As co-lead of the Study Core Team, the CS leads via a matrix organization to execute studies.

ROLE RESPONSIBILITIES

Responsible for supporting complex or leading low complexity studies across various SOPs, including tasks related to: protocol and protocol specific training; vendor management, study level planning and oversight; data review; regulatory document; study report and publication preparation and review; overall study execution with a critical focus on consistency, quality, data integrity, safety, and alignment with company processes.Works in a global environment on studies across all regions including International, Emerging Markets and China.May represent line in program-wide functions and governance as needed. Contributes to discussions to ensure consistency across products/TA.Using knowledge of epidemiologic/observational and specific aspects of trials, provides support of operational strategic partner involvement at a program or study level. Identifies issues in a timely manner, leads implementation of solutions, and/or escalates as appropriate.Provides operational input on tactical implementation of studies.

BASIC QUALIFICATIONS

Training and Education

BA/BS Degree in life sciences or health related field with 5+ years practical experience or MS/MBA with 3+ years, PharmD/PhD 2 years, MD/DO with 1 year

 Prior Experience and Capabilities

Industry experience in the Clinical Scientist role or similar capacity.Experience working on multinational teams/studiesHands-on experience in epidemiology study design, conduct and analysis.Experience in or leading study teamsExperience working independently and collaborating with multiple functional groups within and outside the business lineDemonstrated an ability working across multiple studies for incorporation of consistent medical/scientific concepts in multiple protocolsStrong knowledge of the clinical research process and Good Clinical Practices (GCPs), monitoring, clinical and regulatory operationsDemonstrated independent authorship of study protocols and other study documentsWorking knowledge of statistics, data analysis, and data interpretationExperienced in managing external vendors for clinical and/or epidemiological study(ies)Fluent English writing, reading, and speaking and has exceptional written and oral communication and cross-functional collaborative skills. Experience with Power BI will be asset.

We are always excited to connect with great talent. This posting is intended for an [possible] upcoming opportunity rather than a live role. By expressing your interest, you'll be added to our talent pipeline and considered should this role become available.

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.