Uxbridge, Middlesex
Pharmiweb
SUMMARY: The Temp - Clinical Study Specialist (CSS) provides technical and administrative support to the
clinical study team(s) responsible for clinical trial execution. The Temp - CSS may be assigned to support the
execution of one or more studies across a program. The Temp - CSS receives assignments from the Clinical
Study Lead or Clinical Study Associate Manager. The Temp - CSS will support internally sourced studies and
studies out-sourced to Clinical Research Organizations (CROs).
SCOPE:
N/A
JOB RESPONSIBILITIES:
• 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
JOB REQUIREMENTS:
Education
• Bachelor's degree
Experience
• 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
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.
The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.
SUMMARY: The Temp - Clinical Study Specialist (CSS) provides technical and administrative support to the
clinical study team(s) responsible for clinical trial execution. The Temp - CSS may be assigned to support the
execution of one or more studies across a program. The Temp - CSS receives assignments from the Clinical
Study Lead or Clinical Study Associate Manager. The Temp - CSS will support internally sourced studies and
studies out-sourced to Clinical Research Organizations (CROs).
SCOPE:
N/A
JOB RESPONSIBILITIES:
• 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
JOB REQUIREMENTS:
Education
• Bachelor's degree
Experience
• 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
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.
The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.