Description Project Specialist 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.Why Syneos HealthWe 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 responsibilitiesSet-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.Attend, participate, prepare and distribute meeting minutes and action items for both internal and external meetings (sponsor, trusted process, functional, investigator meetings).
Follow up with team members on action items to closure.Maintain timely and effective communication among team members and site staff.
Keep Project Leadership and Clinical Research Associates (CRAs) fully appraised 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.QualificationsWhat we're looking forAssociates 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 HealthOver 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 HealthAdditional 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.#J-18808-Ljbffr
