Senior Clinical Trial Case Manager

BioSpace; King of Prussia (PA); On-site; USD 120,000 - 165,000; Full time

Job summary

CSL Behring seeks a seasoned Pharmacovigilance professional to act as the Case Management SME within cross-functional teams for assigned clinical trials, ensuring compliance with GxP and global regulatory standards. You will manage case management activities, deliver Safety Reporting Plans, and monitor KPIs across the clinical program at a multinational scale.

The role requires 7+ years in PV within pharma, strong knowledge of PV regulations, GxP, and inspections, plus experience with PV

Qualifications

• 7+ years of Pharmacovigilance experience in a multinational pharmaceutical industry environment.
• Expert knowledge of local and international PV regulations and processes.
• Knowledge of local and international GxP regulations, IT standards, and privacy 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.

Responsibilities

• Act as Case Management subject matter expert in cross-functional teams for assigned clinical trials.
• Manage 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.
• Oversee delivery of Safety Reporting Plans and monitor KPIs/KQIs across clinical case management activities.
• Support PV inspections and audits as required.
• Establish and maintain clinical trial case management documents in line with regulations and internal standards.
• Oversee Vendors to ensure GSPV standards for SAE/AESI processing and expedited reporting.
• Act as primary contact for external vendors for all GSPV PV Operations queries.
• Prepare and provide study-specific training to external vendors and GSPV team members.
• Develop and oversee PV procedures to ensure timely processing and analysis of safety data.
• Ensure correct coding of all event and drug terms and inter-/intra-consistency for evaluations.
• Lead or oversee ICSR reporting analyses and CAPAs from clinical trial case management.
• Liaise with internal and external collaborators to meet regulatory reporting requirements.
• Oversee preparation of Suspected Unexpected Serious Adverse Reactions for submission to regulatory agencies.

Skills

Pharmacovigilance

Regulatory knowledge

GxP regulations

Regulatory inspections

Data management

SOP development

PV software tools

GxP environment

Education

Bachelor's degree in Life Sciences

Master's or PhD in Life Sciences (preferred)

Tools

PV software systems

Job description

The Role

Acts as Case Management subject matter expert in cross-functional teams for assigned clinical trials.

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.