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    • Previous experience delivering participant-facing clinical research visits.
    • At least two years’ relevant clinical research delivery experience.
    • Conducting clinical or epidemiological research: 3 years (preferred).
    • Demonstrated experience of conducting epidemiological field studies or clinical research…
    • This role involves leading R&D projects, helping to optimize current and develop new technologies, and supporting technical and clinical teams.
    • MUST HAVE: Experience in clinical trials..
    • Credentialing:* Ensure every doctor and team member involved in research holds valid, up-to-date certifications,…
    • Research experience involving children, families or vulnerable populations, including participant/research-governance administration or online survey/research…
    • Bringing clinical and pharmacovigilance quality under one leader is a deliberate choice.
    • Assuring the quality systems behind clinical development and…
    • Familiar with reproducible research practices (notebooks, scripts, version control, workflow tools).
    • 3+ years hands on analyzing real biological data in…
    • Familiar with reproducible research practices (notebooks, scripts, version control, workflow tools).
    • 3+ years hands on analyzing real biological data in…
    • As the employer, The Windrush Medical Practice may enter into agreements with other local practices or organisations to jointly undertake clinical trials or…
    • Experience writing clinical study protocols and clinical study reports directly.
    • Lead all scientific elements of clinical studies from protocol development…
    • Significant relevant clinical research experience in the pharmaceutical industry.
    • Represent CSL in external forums, making the case for patient- and site-…
    • Responsible for all scientific and operational statistical work for assigned clinical trials and observational studies, or real world data investigations.
    • Familiar with reproducible research practices (notebooks, scripts, version control, workflow tools).
    • 3+ years hands on analyzing real biological data in…
    • Key requirements: * Experience in patient care - 2+ years minimum * Experience in clinical evaluation, clinical data assessment, and medical statistics -…
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    • Advanced scientific degree required (MD, PharmD, or PhD) with strong grounding in clinical research, therapeutic science, and evidence-based medicine.

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Job Post Details

Senior Case Processing Oversight Manager
CSL Behring
·
3.2
Maidenhead
Full-time

Job details

Pay information not provided
Full-time
Maidenhead

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-263752

Job Description

The position is part of a team responsible for continuous analysis of global documents and regulatory intelligence from interface functions to decide on relevant updates to regulatory and business reporting requirements.
Key Responsibilities
Oversee follow-up activities to ensure that follow-up of cases is done in accordance with the procedural documents
Oversee the assessment and the handling of literature articles identified by the Global Literature Office and local literature articles identified by the Safety Officers
Serve as case processing Subject Matter Expert (SME) for the input into procedural documents for case processing-related processes (e.g. SOPs, GDLs, work instructions); SME for incorporating process changes into the training material for case processing and for reviewing it for accuracy.
Collaborate with GSPV and external stakeholders to improve/ optimize case management processes including the development of SOPs and WIs in collaboration with other functions.
Maintain the tracking tool where new process decisions are tracked and ensuring that users are informed.
Supporting the investigation / assessment of ICSR compliance activities where required
Reg Intelligence (RING) assessment to decide on relevant updates or the impact on case processing due to regulatory updates.
Audit and inspection readiness including corrective & preventive action (CAPA) management.
SME for the initiatives or projects in the context of case processing
Skills and Experience Required
Minimum of 10 years of Clinical Trial and Post-marketing Pharmacovigilance (PV) experience.
Global pharmacovigilance database knowledge is required along with proficient knowledge of global and local regulatory rules and regulations.
Direct experience authoring/ updating SOPs, work instructions
Qualifications and Educations Required
BS/BA, RN, Pharmacist, or similar.

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.

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