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Clinical Research Director - Oncology Experience Required

Syneos Health

United States

Description

Principal Clinical Research Scientist

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•    Acts as a scientific consultant and provides scientific and regulatory support to clients and internal teams.•    Provides scientific support/ strategy on highly complex study designs.•    Plans and develops Early Phase study designs/synopses/protocols and related documents, as well as all related Quality control activities. •    Ensures that study designs are adequate and meet study objectives while ensuring subject safety.•    Participates in reviewing Early Phase protocols prepared by clients.•    Participates in reviewing project documents prepared by other internal teams (e.g.: SAP, Clinical Study Report, etc.)•    Accountable for scientific leadership and deliverables on assigned activities throughout project conduct.•    Creates/reviews SOPs•    Actively participates in regulatory monitoring/intelligence; prepares, revises and updates scientific databases (e.g.: Scientia) used by other internal teams.•    Keeps track of assigned documents/deliverables until the end of the study, and delivers within required timelines; addresses and manages related issues.•    Independently prepares and presents scientific material at internal and client calls.•    Synthesizes and integrates into the documents (e.g.: protocols) comments made by clients, internal stakeholders, the ethics committee and regulatory agencies (pre and post study).•    May prepare, review and submit clinical trial applications for approval by Health Canada and perform the necessary monitoring to ensure that all regulatory requirements to begin a study are met.•    May prepare communications intended to regulatory agencies to ensure the feasibility and compliance of clinical trial applications at the regulatory level.•    Participates in bid defense meetings.•    Develops strong relationships with current clients to help generate new and/or add-on business for the future.•    Train, support and coach junior team members. Facilitates team training in accordance with design/project/regulatory/process requirements.•    May be required to line manage team members.

Qualifications

What we’re looking for •    Master’s Degree (or equivalent) level of qualification in life science. •    Strong knowledge of Good Clinical Practice/ICH guidelines, regulatory requirements, drug development process, literature research. •    Clinical research organization (CRO) preferred. •    Strong ability to manage time and work independently. •    Must demonstrate good computer skills especially in the utilization of Microsoft Word, Excel, PowerPoint, and Acrobat software; ability to embrace new technologies. •    Excellent communication, presentation, interpersonal skills, both written and spoken (English required), with an ability to inform, influence, convince, and persuade. •    Flexibility and the ability to mentor and/or manage new staff and to handle multiple tasks to meet deadlines delivering high quality work in a dynamic environment.

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.

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.

Job posted: 2024-06-14

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