Syneos Health LLC
Study Manager - Immunology
USA-NC-Remote · Staff+
Sponsorship not specifiedDetected 51 days ago
GCPProject ManagementClinical TrialsClinical ResearchFDA RegulatoryResearchLeadershipCommunicationGxP
About the role
- Study Manager - Immunology 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.
Responsibilities
- Further, nothing contained herein should be construed to create an employment contract.
- 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 continuously building the company we all want to work for and our customers want to work with.
- 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.
- Manages a project as a project manager overseeing interdisciplinary clinical research studies and ensures compliance with GCP, relevant SOP's, and regulatory requirements.
Requirements
- Direct therapeutic area expertise.
- Ability to embrace new technologies.
- Ability to travel as necessary (approximately 25%).
- Bachelor's Degree (or equivalent) level of qualification in life sciences, Medicine, Pharmacy, Nursing or equivalent combination of education and experience.
- Clinical research organization (CRO) and relevant therapeutic experience preferred. Strong knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements
- Strong organizational skills.
- Strong ability to manage time and work independently.
- Excellent communication, presentation, interpersonal skills, both written and spoken.
- We are always excited to connect with great talent. This posting is intended for a [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.
- At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements.
Nice to have
- Clinical research organization (CRO) and relevant therapeutic experience preferred.
- Strong knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements
Compensation
- The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role.
- 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.
- 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.
Benefits
- Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success.
- 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.
- 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.
Company info
- The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities.
- The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above.
- 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.
- We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.
- 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.
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