Clinical Study Specialist
5 months ago
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).
This role is a hybrid position and must work onsite 3 days per week. Fully remote is not possible for this role.
**In this role, a typical day might include the following**:
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, enrollment 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
**This role might be for you if**:
You have a strong attention to details for the ability to track information and deliver on assigned study activities
You demonstrate strong communication and interpersonal skills; ability to form relationships internally and externally
You are resourceful and to demonstrate problem solving skills
You can proactively assess information and investigate impact on clinical trials
In order to be considered, a Bachelor’s degree with 2+ years of relevant pharmaceutical industry experience. In lieu of a Bachelor’s Degree 5+ years of relevant pharmaceutical industry experience is required with a focus in clinical operations or trial management.
Salary Range (annually) $90,700.00 - $148,100.00
-
Clinical Project Associate
2 weeks ago
Uxbridge, United Kingdom Regeneron Pharmaceuticals, Inc Full time**Study Execution Specialist Role**The Clinical Study Specialist provides technical and administrative support to the clinical study team responsible for the successful execution of clinical trials. This role involves scheduling meetings, preparing agendas, and coordinating study-related activities.The ideal candidate will have a Bachelor's degree with...
-
Global Clinical Study Director
3 weeks ago
Uxbridge, United Kingdom Pharmiweb Full timeJob DescriptionWe are seeking a highly experienced Global Clinical Study Director to lead our team in the execution of global clinical trials. The ideal candidate will have a strong background in clinical operations, excellent leadership skills, and the ability to work independently with minimal supervision.Key ResponsibilitiesDevelop and implement...
-
Senior Clinical Study Manager
3 weeks ago
Uxbridge, United Kingdom Regeneron Pharmaceuticals, Inc Full timeJob Summary: We are seeking a highly skilled and experienced Senior Clinical Study Manager to lead the global execution of assigned large and/or complex clinical trials from study design, through execution, to study close out.Key Responsibilities:Leads the cross-functional study team responsible for clinical study delivery and is the primary point of contact...
-
Sr. Manager Clinical Study Lead
3 weeks ago
Uxbridge, United Kingdom Pharmiweb Full timeThe Senior Clinical Study Lead (CSL) is expected to operate with high-degree of independence and is accountable for the global execution of assigned large and/or complex clinical trials from study design, through execution, to study close out. The Senior CSL is accountable for the study timelines, study budget, and ensuring study conduct is in accordance...
-
Clinical Operations Director
4 weeks ago
Uxbridge, United Kingdom CTI Clinical Trial and Consulting Services Full timeParexel is currently seeking a Clinical Operations Director to join us in the UK.This role offers tremendous long-term job security and prospects.Our Clinical Operations Directors work from their home office base, supporting studies within their country or region.Responsible at country level to deliver committed components of clinical studies according to...
-
Clinical Trials Director
4 weeks ago
Uxbridge, United Kingdom CTI Clinical Trial and Consulting Services Full timeParexel is currently seeking a highly skilled Clinical Trials Director to join their team in the UK.As a Clinical Trials Director at Parexel FSP, you will have the opportunity to work from your home office base, supporting studies within your country or region.Responsible at country level to deliver committed components of clinical studies according to...
-
Global Study Lead Specialist
1 day ago
Uxbridge, United Kingdom Regeneron Pharmaceuticals, Inc Full timeAbout UsRegeneron Pharmaceuticals, Inc. is a leading biotechnology company that discovers, develops, and commercializes innovative medicines for serious diseases.Our Mission:To create a healthier world by pioneering new treatments for patients with serious diseases.What We Offer:A competitive salary range of $120,000 - $180,000 per year.A comprehensive...
-
Senior Manager Clinical Study Lead
5 days ago
Uxbridge, London , Uxbridge, London, London, United Kingdom Regeneron Full timeThe Senior Manager Clinical Study Lead (CSL) is expected to operate with high-degree of independence and is accountable for the global execution of assigned large and/or complex clinical trials from study design, through execution, to study close out. The Senior CSL is accountable for the study timelines, study budget, and ensuring study conduct is in...
-
Senior Study Manager
1 day ago
Uxbridge, United Kingdom Regeneron Full timeKey ResponsibilitiesAs a Sr. Manager, Clinical Study Lead, your key responsibilities will include:Leading the cross-functional study team responsible for clinical study deliveryDeveloping study-specific documentation, including case report forms (CRF) and data management plansEnsuring compliance with clinical trial registry requirements and identifying...
-
Clinical Study Manager
1 month ago
Uxbridge, United Kingdom Amgen Inc. (IR) Full timeJob Summary:In this vital role, you will oversee the management and coordination of clinical budget and related pricing strategy services for Clinical Study Teams. You will provide senior-level supervision, support, and management of Clinical Payments Systems staff to ensure consistent and compliant payments to clinical sites globally.Key...
-
Study Operations Executive
2 days ago
Uxbridge, United Kingdom Pharmiweb Full timeJob Title: Study Operations ExecutiveAbout PharmiwebWe are a leading provider of clinical trial management services, dedicated to helping pharmaceutical companies bring life-changing treatments to market. Our team is passionate about delivering exceptional results and making a difference in people's lives.Estimated Salary: $160,000 - $220,000 per yearJob...
-
Clinical Operations Manager
1 day ago
Uxbridge, United Kingdom Pharmiweb Full timeJob DescriptionWe are seeking a highly skilled and experienced Clinical Operations Manager to join our team at Pharmiweb. As a key member of our clinical operations team, you will be responsible for leading the execution of large and complex clinical trials from study design through close out.This role is ideal for individuals with a strong background in...
-
Clinical Research Fellow
1 month ago
Uxbridge, United Kingdom Guy's and St Thomas' NHS Foundation Trust Full timeJob Title: Clinical Research Fellow - Advanced Heart Failure SpecialistWe are seeking a highly motivated and experienced Clinical Research Fellow to join our team at Guy's and St Thomas' NHS Foundation Trust. The successful candidate will be involved in an epidemiological study related to advanced heart failure, cardiac transplantation, and left ventricular...
-
Clinical Operations Director
4 weeks ago
Uxbridge, United Kingdom Parexel Full timeAbout the RoleParexel is seeking a Clinical Operations Leader to join our team in the UK. As a Local Study Associate Director, you will be responsible for delivering clinical studies according to agreed resources, budget, and timelines, complying with Client Procedural Documents, international guidelines, and relevant local regulations.Key...
-
Clinical Operations Manager
2 days ago
Uxbridge, United Kingdom Regeneron Full timeJob DescriptionThe Sr. Manager, Clinical Study Lead role at Regeneron is an exciting opportunity for experienced professionals to take on a leadership position in global clinical trial operations.We are seeking a highly skilled and motivated individual to lead the execution of large and complex clinical trials from study design through execution to study...
-
Clinical Operations Director
4 weeks ago
Uxbridge, United Kingdom Parexel Full timeAbout the RoleParexel is seeking a skilled Clinical Operations Leader to join our team in the UK. As a Local Study Associate Director, you will be responsible for delivering clinical studies according to agreed resources, budget, and timelines, complying with Client Procedural Documents, international guidelines, and relevant local regulations.Key...
-
Clinical Operations Director
4 weeks ago
Uxbridge, United Kingdom Pharmiweb Full timeJob SummaryThis role is a hybrid position which requires a minimum 3 days on-site in a designated location. Remote work is not an option for this role. The Clinical Operations Director will lead and implement the operational strategy for delivery of one or more complex programs in Clinical Trial Management (CTM). This individual is responsible for clinical...
-
Clinical Trials Director
4 weeks ago
Uxbridge, United Kingdom Parexel Full timeAbout the RoleParexel is seeking a Country Study Lead to join our team in the UK. As a key member of our local team, you will be responsible for delivering clinical studies according to agreed resources, budget, and timelines, complying with client procedural documents, international guidelines, and relevant local regulations.Key ResponsibilitiesEnsure...
-
Clinical Operations Manager
2 days ago
Uxbridge, United Kingdom Pharmiweb Full time**Job Title:** Clinical Operations Manager - Global Clinical Trial Lead**Company Overview:** At Pharmiweb, we are a leading provider of clinical trial management solutions. We are seeking an experienced Clinical Operations Manager - Global Clinical Trial Lead to join our team.**Salary Range:** $120,000 - $180,000 per year (dependent on location and...
-
Clinical Trials Director
4 weeks ago
Uxbridge, United Kingdom Parexel Full timeUnlock Your Potential in Clinical ResearchParexel is seeking a dedicated Clinical Trials Director to join our team in the UK. As a key member of our team, you will be responsible for delivering clinical studies according to agreed resources, budget, and timelines, complying with client procedural documents, international guidelines, and local regulations.Key...