Study manager Work, Jobs in Berkhamsted, Hrt (with Salaries)

Manager, Clinical Study Lead
Regeneron —Uxbridge
- Bachelor's degree
- Continuous improvement
- Travel
- Annual leave
Brand Manager
Bunzl UK & Ireland Portfolio Brands —Slough
- £40,000 - £60,000 a year
- Full-time
- Quality control
- SharePoint
- In-person
Quick apply
4d
Business Administration Manager
Signature Senior Lifestyle —Ascot
- £34,650 - £42,350 a year
- Remote
- Administrative experience
- Human resources
- Recruiting
- Annual leave
- Employee assistance programme
Account Manager - UK
sunday —London
- £45,000 - £55,000 a year
- Hybrid work
- Hospitality
- Analysis skills
- Project management
Registered Manager of 16-17 Supported Accommodation
YMCA MK —Milton Keynes
- £45,000 - £50,000 a year
- Full-time
- In-person
- Leadership
- Communication skills
- Employee discount
Quick apply
11d
Senior Customer Success Manager
Stream —London
- From £60,000 a year
- Hybrid work
- Travel
- Annual leave
Quick apply
Senior Account Manager
Audience Collective —London
- £48,000 - £50,000 a year
- Remote
- Continuous improvement
Quick apply
QC Analyst
Prime Labs Ltd —Watford
- Part-time
- Microsoft Word
- Microsoft Excel
- Quality control
Quick apply
13d
Home Admissions Officer
Buckinghamshire New University —High Wycombe
- £29,588 - £33,002 a year
- Weekend availability
- Hybrid work
- Continuous improvement
- Recruiting
- Organisational skills
- Annual leave
- Employee discount
7h
Global Medical Affairs Research Grant & Study Manager
Santen —St Albans
- £78,863 - £108,436 a year
- Full-time
- Remote
- Nursing
- Doctoral degree
- English
Quick apply
11d
Regional Manager
Trinity Estates —Hemel Hempstead
- Monday to Friday
- Hybrid work
- Employee discount
- Referral programme
Business Administration Officer
Luton Town Football Club —Luton
- Part-time
- Salesforce
- Writing skills
- Microsoft Office
Audit Trainee
TC-Group —London
- Full-time
- Hybrid work
- Data analysis skills
- Analysis skills
- Organisational skills
- Annual leave
- Employee assistance programme
Quick apply
5d
HPL – Global Studies – NCUK Centre
Malvern International PLC —London
- From £25 an hour
- Master's degree
- University
- Travel
Quick apply
6d
Marketing Manager
Glenholme Healthcare Ltd —Eton
- £40,000 - £45,000 a year
- Full-time
- Analysis skills
- Team management
- Travel
- Annual leave
- Employee assistance programme
Quick apply
Senior Digital Campaigns Manager
universityoflondon —London
- From £51,525 a year
- Hybrid work
- University
11d
Digital Marketing Manager
cinch —Milton Keynes
- £46,700 - £56,000 a year
- Monday to Friday
- Hybrid work
- Analysis skills
- Team management
- Leadership
- Employee assistance programme
Quick apply
Delivery Driver
Thirsty Work —Hemel Hempstead
- £27,613.14 a year
- Full-time
- Customer service
- Plumbing
- Driving
Quick apply
10h
International Admissions Officer
Buckinghamshire New University —High Wycombe
- £29,588 - £33,002 a year
- Weekend availability
- Hybrid work
- Nursing
- Administrative experience
- University
- Annual leave
- Employee discount
7d
Property Manager
Trinity Estates —Hemel Hempstead
- Monday to Friday
- Hybrid work
- Customer service
- Employee discount
- Referral programme
12d

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Manager, Clinical Study Lead

Regeneron -
Uxbridge

Apply Now

Job details

Benefits

Annual leave
Company pension

Qualifications

Healthcare research operations
Contract management
Clinical research
Bachelor's degree
Continuous improvement
Recruiting
Organisational skills
Project schedule tracking
Good Clinical Practice (GCP)
Leadership
Good Clinical Practice (ICH-GCP) guidelines
Project progress tracking

Full job description

Build our future together:

The Manager, Clinical Study Lead may perform the following responsibilities with moderate oversight: accountable for the global execution of assigned smaller or less complex clinical trials from study design, through execution, to study close out. You are accountable for the study timelines, study budget, and ensuring study conduct is in accordance with Regeneron Standard Operating Procedures (SOPs) and ICH/GCP. This role applies to internally sourced studies and studies outsourced to Clinical Research Organizations (CROs) and the balance of direct leadership versus oversight will vary accordingly. Contributes and drives ongoing process improvement initiatives.

When & where:

Work Location: Uxbridge, UK

25% Travel may be required

Discover your role:

Leads the cross-functional study team responsible for clinical study delivery, serving as the primary point of contact for leadership and oversight, and oversees execution against planned timelines, deliverables, and budget while raising issues (conduct, quality, timelines, budget) to the Program Operations Lead and stakeholders and implementing corrective action
Provides operational input into protocol development; leads feasibility assessments to select relevant regions and countries; oversees or conducts site evaluation and selection; and leads investigator meeting preparation and execution
Oversees and contributes to study documentation, including case report forms, data management plan, monitoring plan, monitoring oversight plan, project-specific training plan, data review plan, statistical analysis plan, and related materials
Oversees set-up and maintenance of study systems (e.g., CTMS, TMF) and ensures compliance with clinical trial registry requirements
Identifies outsourcing needs and leads vendor engagement, contracting, and management; ensures CROs and third-party vendors are aligned and delivering per scope of work
Provides input into baseline budget and timeline development and management; ensures accurate budget management and scope change control for internal and external studies
Leads study-level risk assessment and mitigation; monitors site activation and monitoring visits and acts on deviations; leads development and oversees implementation of patient recruitment and retention strategies and responds to deviations from plan; and monitors data entry and query resolution against agreed metrics
Manages study close-out activities, including database lock, reconciliation of vendor contracts, budget, TMF, and study drug accountability; contributes to clinical study report writing and review; and facilitates study-level lessons learned
Assigns tasks to Clinical Study Management staff and supports their deliverables; directly supervises CTM staff (work assignments, performance management, recruitment, professional development, coaching, mentoring, ongoing training and compliance, and study support/oversight); recommends and participates in cross-functional and departmental process improvements; and identifies innovative, globally informed approaches to study execution and continuous improvement of CTM SOPs
May be assigned unmasked tasks for studies, which may include but is not limited to, assisting with masked investigational product, set up and management of unmasked trial master file, review of unmasked data in the electronic data capture system, point of contact for IVRS issues, and support oversight of unmasked clinical monitoring

This role requires:

Bachelor’s degree and have at least six years of relevant industry experience
Extensive budget management expertise; a proven ability to build productive study teams and collaborations; and demonstrated vendor management experience
Strong technical proficiency with trial management systems and Microsoft applications is required, including Project, PowerPoint, Word, Excel, and platforms such as IVRS/IWRS and EDC
Experience in global clinical trial operations, including developing protocols and key study documents; solid knowledge of ICH/GCP and relevant regulatory guidelines and directives; and effective project management, cross-functional team leadership, and organizational skills
Ability to understand and implement the operational strategic direction and guidance for respective clinical studies

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. 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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Apply Now

Refine Your Search

study manager jobs in berkhamsted, hrt

Manager, Clinical Study Lead

Brand Manager

Business Administration Manager

Account Manager - UK

Registered Manager of 16-17 Supported Accommodation

Senior Customer Success Manager

Senior Account Manager

QC Analyst

Home Admissions Officer

Global Medical Affairs Research Grant & Study Manager

Regional Manager

Business Administration Officer

Audit Trainee

HPL – Global Studies – NCUK Centre

Marketing Manager

Senior Digital Campaigns Manager

Digital Marketing Manager

Delivery Driver

International Admissions Officer

Property Manager

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