Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.
The Clinical Study Specialist (CSS) provides technical and administrative support to the clinical study team(s) responsible for clinical trial execution. The CSS may be assigned to support the execution of one or more studies across a program. The CSS receives assignments from the Clinical Study Lead or Clinical Study Associate Manager. The CSS will support internally sourced studies and studies out-sourced to Clinical Research Organizations (CROs).
Organizes and delivers analyzable reports and metrics to the clinical study lead
Schedules and coordinates meetings, prepares agendas, presentation materials and minutes for clinical study team meetings and other study related meetings
Collates data for assessments such as feasibility and site selection and reviews site usability database
Contributes to review of study documents such as informed consent forms, case report forms and facilitates study document reviews per company standard operating procedures
Compiles study manuals including but not limited to: study reference binders and manuals and maintains versioning of study reference materials (e.g., regulatory, pharmacy, and laboratory binders
Collates materials for training and investigator meetings
Tracks site activation, enrolment and monitoring visits to projected plans, and escalate any issues or delays with site activation or deviations from monitoring plan
Monitors and updates investigator/site status for the trial, and supports with clinical trial registry postings
Performs scheduled reconciliations of study Trial Master File (TMF) with clinical study lead guidance
Ensures scheduled reports are received (i.e. 1572 reportable changes, financial disclosure form)
Manages and maintains team SharePoint and/or shared drive sites, as needed
Communication with sites as directed and maintains site contact information
Contributes to line listings review for Blind Data Review Meeting (BDRM)
May manage or contribute to oversight of Third Party Vendors (TPV)
Tracks and monitors close out activities study close-out documents (1572s, Investigational Product reconciliation, Financial Disclosures, etc.) and CRA close-out visits
Participates in Standard Operating Procedures (SOPs) revisions or departmental initiatives
Proactively recommends process improvement initiatives for the department
Attention to details for the ability to track information and deliver on assigned study activities
Good communication and interpersonal skills; ability to build relationships internally and externally
Ability to be resourceful and to demonstrate problem solving skills
Demonstrate the ability to proactively assess information and investigate impact on clinical trials
Ability to acquire working knowledge in trial management systems and MS applications including (but not limited to) Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC, TMF
Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization
Basic familiarity with medical terms and clinical drug development
Awareness of ICH/GCP
Bachelor's degree and a minimum of 2+ years' industry related work experience or an advanced degree in a related field with a minimum of one (1) to two (2) years of relevant work preferred.
This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.
To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.