Senior clinical data manager Work, Jobs in Maidenhead, Brk (with Salaries)

Senior Clinical Trial Case Manager
CSL Behring —Maidenhead
- Full-time
- Doctoral degree
- Master's degree
- Bachelor's degree
14d
Senior Manager, Clinical Operations - FSP Resource & Vendor Management
CSL Behring —Maidenhead
- £170,000 - £201,000 a year
- Full-time
- Master's degree
- Bachelor's degree
Senior Business and Performance Improvement Manager
Surrey and Borders Partnership NHS Foundation Trust —Leatherhead
- £68,852 - £79,638 a year
- Full-time
- Continuous improvement
- Analytics
- Free parking
9d
Senior Product Manager
Clinisys —Woking
- Remote
- Machine learning
- AI
- Leadership
Senior Data Analyst
Imperial College Healthcare NHS Trust —London
- £58,133 - £65,261 a year
- Full-time
- Data analysis skills
- Communication skills
2d
Senior Clinical Data Manager - sponsor dedicated - oncology
Fortrea —Maidenhead
- Full-time
- Remote
- Presentation skills
- Mentoring
- Leadership
Clinical Services Manager
Circle Health Group —Harrow
- Up to £70,000 a year
- Full-time
- Hospital
- Data analysis skills
- Master's degree
- Annual leave
- Employee discount
Senior Business Development Manager
PHSGroup —Middlesex
- £73,500 a year
- CRM software
- Business development
- Travel
- Work from home
Senior Quality Assurance Manager (Clinical)
Bio Pharma Resourcing —Thames Valley
- £35,000 - £40,000 a year
- Computer literacy
- Travel
- Computer skills
Senior CRA
Fortrea —Maidenhead
- Full-time
- Communication skills
Senior Data Scientist (FTC)
UK Health Security Agency —Colindale
- £46,310 - £52,113 a year
- Part-time
- Remote
- Computer Science
- Presentation skills
- Bachelor's degree
1d
Clinical Data Manager - FSP (Homebased - UK)
IQVIA —Reading
- Full-time
- Remote
- Bachelor's degree
- Quality control
- Work from home
7d
Group Quality and Compliance Manager
Kimbolton Lodge Ltd —Uxbridge
- £50,000 - £60,000 a year
- Full-time
- Hybrid work
- Continuous improvement
- Travel
- Training & development
Quick apply
12d
Data Team Lead
IQVIA —Reading
- Full-time
- Remote
- Bachelor's degree
- Mentoring
- Leadership
- Work from home
Key Account Manager - Oncology (UK & Ireland)
Boehringer Ingelheim Ltd. —Bracknell Forest
- Full-time
- CRM software
- Computer literacy
- Data analysis skills
Sr Director, Drug Development Lead
IQVIA —Reading
- Full-time
- Remote
- Management
- Doctoral degree
- Master's degree
- Work from home
4d
Senior Regulatory Affairs Specialist
Kenvue —Reading
- Hybrid work
- English
- Bachelor's degree
- Organisational skills
- Annual leave
Senior Financial Analyst (Costing and SLR)
Ashford and St. Peter's Hospitals NHS Foundation Trust —Chertsey
- £41,957 - £50,387 a year
- Full-time
- In-person
- Communication skills
- Annual leave
- Employee discount
Clinical Services Manager – Oncology
Circle Health Group —Harrow
- Full-time
- Hospital
- Recruiting
- Leadership
- Employee discount
- Life insurance
Operations Manager
Brownbill Associates —Thame
- Full-time
- Continuous improvement
- Team management
- Case management
- Annual leave
- Employee assistance programme
Quick apply

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Senior Clinical Trial Case Manager

CSL Behring -
Maidenhead

Apply Now

Job details

Full-time
14 days ago

Qualifications

Clinical research
Doctoral degree
Stakeholder liaison
Master's degree
Bachelor's degree
Pharmaceutical industry setting experience
Corporate regulatory compliance oversight

Full job description

Entity: CSL Behring

Job Category: Research Development & Sciences

Job Family: Pharmacovigilance Operations

Job Type: Full Time

Location: Maidenhead, England, United Kingdom

Employer Reference: R-284355

Job Description

The Role:

Acts as Case Management subject matter expert in cross-functional teams for assigned clinical trials.
Manages case management activities for assigned clinical studies to ensure compliance with national and international regulations, such as GxP guidelines and/or other relevant international and national legislation, regulations, guidance, and company policies and procedures within the area of responsibility.
Manages the delivery of the Safety Reporting Plans, ; identifies, implements, and monitors KPIs/KQIs across clinical case management activities;
Supports the preparation and conduct of PV and other GxP inspections and audits, as required, .
Establishes, maintains, and/or ensures maintenance of clinical trial case management required documents, such as safety reporting plans and reporting responsibilities , in line with international and national regulations, guidelines, and internal standards.
Oversee the Vendors to ensure GSPV standards are maintained with respect to processing of SAE, AESI and pregnancy clinical trial cases and compliance with respect to expedited reporting in clinical trials.
Act as primary contact for external vendors for all GSPV PV Operations clinical trial queries pertaining to their assigned Clinical trials.
Prepare & Provide Study specific training to external vendors and GSPV team members involved in the given clinical trial.
Participate in any drug safety database enhancements and upgrades by providing input from a clinical trial perspective.
Develops, implements, and oversees pharmacovigilance procedures and processes and ensures the uniform and timely processing and analysis of safety data to comply with regulatory requirements.
Ensures correct coding of all event and drug terms.
Ensures inter- and intra-consistency for case evaluations.
Leads or oversees ICSR reporting compliance analyses provided by vendors and associated CAPAs from clinical trial case management.
Acts as a liaison internally and with external collaborators to develop processes that meet regulatory reporting requirements.
Oversees preparation of Suspected Unexpected Serious Adverse Reactions for submission to external regulatory agencies.
May lead or contribute to cross-functional projects to fulfill GxP requirements and improve inspection readiness.

Skills and Experience:

Bachelor's degree or equivalent in a life science discipline (e.g., nursing, biological sciences, pharmaceutical sciences, or Medical Documentation). Master's or PhD in Life Sciences preferred.
7+ years of Pharmacovigilance experience in a multinational pharmaceutical industry environment.
Expert knowledge of local and international regulations and PV processes.
Knowledge of local and international GxP regulations, IT standards, and other relevant legislation, including privacy protection requirements.
Experience with regulatory inspections.
Experience administering complex data sets.
Experience managing CAPA and SOP development projects.
Experience with relevant software applications.
Experience working within a GxP-regulated environment.

About CSL Behring

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.

To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.

Our Benefits

For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.

You Belong at CSL

At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging

Equal Opportunity Employer

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.

Apply Now

Refine Your Search

senior clinical data manager jobs in maidenhead, brk

Senior Clinical Trial Case Manager

Senior Manager, Clinical Operations - FSP Resource & Vendor Management

Senior Business and Performance Improvement Manager

Senior Product Manager

Senior Data Analyst

Senior Clinical Data Manager - sponsor dedicated - oncology

Clinical Services Manager

Senior Business Development Manager

Senior Quality Assurance Manager (Clinical)

Senior CRA

Senior Data Scientist (FTC)

Clinical Data Manager - FSP (Homebased - UK)

Group Quality and Compliance Manager

Data Team Lead

Key Account Manager - Oncology (UK & Ireland)

Sr Director, Drug Development Lead

Senior Regulatory Affairs Specialist

Senior Financial Analyst (Costing and SLR)

Clinical Services Manager – Oncology

Operations Manager

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About CSL Behring

Our Benefits

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Equal Opportunity Employer

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