Senior clinical data manager Work, Jobs in London, Gtl (with Salaries)

Senior Manager, PV Operations
Orchard Therapeutics —London
- Full-time
- Hybrid work
- Writing skills
- Microsoft Office
- Bachelor's degree
Quick apply
Senior Product Manager
Semble —London
- £75,000 - £95,000 a year
- Remote
- Analysis skills
- Project management
- Travel
Quick apply
Senior Product Manager
Healthtech-1 —London
- £2,500 a week
- Overtime
- Product management
- School
- Annual leave
- Work from home
2d
Senior Product Manager, AI & Data Products
Surgo Health —London
- £84,000 - £107,000 a year
- Full-time
- Hybrid work
- Machine learning
- Product management
- Travel
- Annual leave
Quick apply
Senior Manager, Medical Communications
Orchard Therapeutics —London
- Full-time
- Hybrid work
- Doctoral degree
- Master's degree
- Project management
Quick apply
Clinical Data Manager - FSP (Homebased - UK)
IQVIA —London
- Full-time
- Remote
- Bachelor's degree
- Quality control
- Work from home
7d
CMC Associate Director
Androlabs —London
- £85,000 - £108,000 a year
- Full-time
- Hybrid work
- Continuous improvement
- Budgeting
- Manufacturing
- Annual leave
Quick apply
Senior Data Analyst
Imperial College Healthcare NHS Trust —London
- £58,133 - £65,261 a year
- Full-time
- Data analysis skills
- Communication skills
2d
Clinical Data Strategy, Manager
Novartis —London
- £49,140 - £91,260 a year
- Full-time
- Hybrid work
Senior Clinical Project Manager (Renal, Obesity, MASH) - Global Study Leadership
IQVIA —London
- Full-time
- Remote
- Bachelor's degree
- Team management
- Leadership
- Work from home
Senior Strategy & Operations Manager - Obesity
Voy —London
- Hybrid work
- AI
- Marketing
Quick apply
Senior Product Manager
Nucs AI —London
- Full-time
- Hybrid work
- English
- Bachelor's degree
- Product management
Quick apply
Senior Product Manager
Clinisys —Woking
- Remote
- Machine learning
- AI
- Leadership
Senior Product Manager - New Bets
Voy —London
- Hybrid work
- Business development
- Communication skills
Quick apply
1d
Senior Feasibility Associate / Feasibility Manager
Precision for Medicine —London
- Remote
- Microsoft Powerpoint
- Microsoft Word
- Writing skills
Quick apply
Senior Consultant, Healthcare Strategy & Planning (Health & Life Sciences)
WSP —London
- Part-time
- Hybrid work
- Writing skills
- Research
- Business development
- Flexitime
- Work from home
Clinical Services Manager - 0-19 Universal Services
Central London Community Healthcare NHS Trust —London
- £72,719 - £83,505 a year
- Full-time
- Management
- Continuous improvement
- Rehabilitation centre
14d
Senior Apprenticeships Development Manager
NHS England —London
- £66,582 - £77,368 a year
- Part-time
- Master's degree
- Annual leave
3d
Head of Clinical Operations
Dispensed —London
- £60,000 - £90,000 a year
- Full-time
- Hybrid work
- Management
- Travel
- Recruiting
Quick apply
8d
Senior Implementation Manager - R&D Advisory
Syneos Health Commercial Solutions —London
- Data analysis skills
- Business development
- Team management

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senior clinical data manager jobs near london, gtl

Senior Manager, PV Operations

Orchard Therapeutics -
London

Quick apply

Job details

Full-time

Qualifications

Clinical research
Writing skills
Regulatory reporting
Internal department liaison
Microsoft Office Suite
Microsoft Office
Database administration
Bachelor's degree
Continuous improvement
Continuous improvement cycles oversight
Risk management
Operational strategy development
Leadership
Communication skills
Internal quality assurance
Corporate regulatory compliance oversight
FDA regulations
Time management

Full job description

Reporting to: VP Pharmacovigilance

Location: London, UK / Hybrid

Orchard Therapeutics is a global biotechnology gene therapy company dedicated to transforming the lives of people affected by rare diseases through the development of innovative, potentially curative cell and gene therapies. Orchard has its global headquarters in London and is a wholly owned subsidiary of Kyowa Kirin, a Japan-based Global Specialty Pharmaceutical Company.

Job Summary

The Senior Manager, PV Operations is a key operational leader responsible for the execution and management of global pharmacovigilance operations. This role on a day to day basis ensures the seamless delivery of case management, regulatory reporting, and operational compliance across clinical and post-marketing portfolios.

This role serves as the primary operational interface for PV vendors and cross‑functional study teams. The Senior Manager, PV Operations is an emerging expert who translates the functional strategy into actionable operational plans, manages complex technical issues with limited guidance, and ensures that the "hands‑on" elements of the PV system are robust, scalable, and inspection‑ready.

Key Elements and Responsibilities

Lead and continuously improve global safety operations processes, including case intake, processing, and submissions, ensuring alignment with global PV regulations and company policies with close oversight of the pharmacovigilance vendors.
Oversee timely and compliant case processing and regulatory reporting of Individual Case Safety Reports (ICSRs) from all sources. Act as database business administrator for the Orchard safety database (Veeva Safety).
Ensure robust operational oversight of internal and external safety case management, including performance monitoring and quality metrics.
Provide strategic leadership for the selection, configuration, validation, and life-cycle management of safety systems and tools, in partnership with IT and Vendor Safety Systems teams.
Lead the design, implementation, and maintenance of standard operating procedures (SOPs), work instructions, and training for safety operations.
Act as key technical SME supporting inspection readiness and support internal audits, Health Authority inspections, and partner audits related to PV operations, coordinating responses and remediation plans.
Liaise with Orchard Quality Assurance colleagues to ensure audit programme of internal and external components of the pharmacovigilance system and partners run smoothly
Collaborate with safety physician, safety scientist and cross-functional teams to ensure efficient processes and systems for production of high-quality data for signal detection, aggregate safety reporting, benefit–risk assessments, and Risk Management Plans (RMPs).
Provide senior operational input into Safety Management Teams and cross-functional project teams, managing operational feasibility, timelines, and compliance risks.
Lead operational aspects of safety data exchange agreements (SDEAs) with partners and licensees and oversee literature surveillance workflows.

Requirements

Education, Experience & Knowledge

Education

Bachelor's degree or equivalent in a life science, pharmacy, nursing, or a related health field.
Relevant certifications in pharmacovigilance or drug safety are highly desirable.

Experience

Extensive experience in pharmacovigilance operations, with significant leadership in global ICSR management and regulatory reporting.
Experience with safety databases (Veeva Safety preferred but not required)
In-depth knowledge of global PV regulations (GVP, ICH, FDA, MHRA, EMA) and proven ability to implement them operationally.
Strong experience with safety databases and PV systems, including configuration, validation, and maintenance.
Demonstrated ability to lead and oversee PV vendors/CROs.
Experience with clinical studies, postmarketing safety, risk management plans and aggregate report preparation.

Desirable

Advanced degree in a relevant scientific or health-related field.
Experience with safety data exchange agreements (SDEAs) and literature surveillance.
Demonstrated ability to drive continuous improvement, process optimization, and automation in PV operations.
Demonstrated understanding of clinical development processes.
Experience with global product launches and implementation/assessment of complex risk minimisation measures.
Evidence of scientific contributions to the field (e.g., peer reviewed publications, invited presentations, guideline development, or recognised subject matter expertise in biologic safety).

Skills & Abilities

Self-motivated, with initiative and ability to take ownership of, and follow through with, specific tasks
Working knowledge of available information sources and ability to navigate multiple channels to secure required information
Works effectively with cross-functional teams to address complex issues and recommend actions with potentially significance impact
Effective time management and organization skills
Ability to multi-task and shift priorities quickly while working under tight deadlines
Excellent verbal and written communication skills
Strong PC experience and demonstrated proficiency in MS Office (Outlook, Word, Excel and Powerpoint)

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Refine Your Search

senior clinical data manager jobs in london, gtl

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CMC Associate Director

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Clinical Data Strategy, Manager

Senior Clinical Project Manager (Renal, Obesity, MASH) - Global Study Leadership

Senior Strategy & Operations Manager - Obesity

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Senior Product Manager

Senior Product Manager - New Bets

Senior Feasibility Associate / Feasibility Manager

Senior Consultant, Healthcare Strategy & Planning (Health & Life Sciences)

Clinical Services Manager - 0-19 Universal Services

Senior Apprenticeships Development Manager

Head of Clinical Operations

Senior Implementation Manager - R&D Advisory

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