Top 62 Clinical research manager Jobs in Philadelphia Pa

Senior Clinical Trial Case Manager
CSL —King of Prussia, PA
- Full-time
- 7 years
- Master's degree
- Bachelor's degree
14d
Senior Manager, Clinical Operations - FSP Resource & Vendor Management
CSL —King of Prussia, PA
- $170,000 - $201,000 a year
- Full-time
- Hybrid work
- 8 years
- Bachelor's degree
- Continuous improvement
Clinical Research Project Manager C
University of Pennsylvania —Philadelphia, PA
- $89,500 - $106,940 a year
- Full-time
- Background check
- 5 years
- HIPAA
- Health insurance
- Dental insurance
Clinical Research Project Manager B
University of Pennsylvania —Philadelphia, PA
- $75,804 - $81,441 a year
- Full-time
- Background check
- 5 years
- Mid-level
- Health insurance
- Dental insurance
Clinical Research Project Manager B (Department of Obstetrics and Gynecology)
University of Pennsylvania —Philadelphia, PA
- $75,804 - $89,789 a year
- Full-time
- Background check
- 5 years
- Master's degree
- Health insurance
- Dental insurance
Clinical Research Project Manager
Thomas Jefferson University and Hospitals —Philadelphia, PA
- Full-time
- 3 years
- Master's degree
- University
- AD&D insurance
- Disability insurance
Clinical Research Program Manager
University of Pennsylvania —Philadelphia, PA
- $75,804 - $81,441 a year
- Full-time
- Microsoft Word
- Background check
- Blood sampling
- Health insurance
- Dental insurance
Clinical Data Manager
American College of Radiology —Philadelphia, PA
- $73,000 - $80,000 a year
- Online Application
- Remote
- Nursing
- Bachelor's degree
- Senior level
- Tuition reimbursement
- Paid time off
4d
Clinical Research Project Manager A
University of Pennsylvania —Philadelphia, PA
- $63,085 - $75,000 a year
- Full-time
- Background check
- 3 years
- University
- Health insurance
- Dental insurance
3d
Clinical Data Manager
BioInforMedica —West Chester, PA
- Mid-level
- Analysis skills
- Bachelor's degree
Clinical Research Lead
Thomas Jefferson University and Hospitals —Philadelphia, PA
- Full-time
- Management
- 3 years
- Master's degree
- AD&D insurance
- Disability insurance
11d
Clinical Development Trial Lead
ICON Plc —Blue Bell, PA
- Full-time
- Remote
- Bachelor's degree
- Training & development
- Senior level
- Disability insurance
- Health insurance
Clinical Project Lead, Oncology
IQVIA —Philadelphia, PA
- $68,400 - $232,800 a year
- Full-time
- Remote
- 3 years
- Bachelor's degree
- Senior level
- Work from home
Project Manager, Imaging and Cardiac
ICON Plc —Blue Bell, PA
- Full-time
- Remote
- English
- Mid-level
- Bachelor's degree
- Disability insurance
- Health insurance
8d
Clinical Operations Lead
Incyte Corporation —Wilmington, DE
- Remote
- Bachelor of Science
- 3 years
- Senior level
Clinical Trial Lead
Novocure —Wayne, PA
- $147,000 - $190,000 a year
- Full-time
- Nursing
- 5 years
- Office
Research Project Manager A
University of Pennsylvania —Philadelphia, PA
- $63,085 - $70,958 a year
- Full-time
- Background check
- Mid-level
- Windows
- Health insurance
- Dental insurance
Sr. Project Manager
MustardSeed PMO —Philadelphia, PA
- $92,000 - $138,000 a year
- Full-time
- Remote
- Organizational skills
- Senior level
- Leadership
- Health savings account
- Paid holidays
Quick Apply
Medical Operations Manager- Philadelphia, PA
The IMA Group —Philadelphia, PA
- Full-time
- Mid-level
- Office
- 3 years
- Paid holidays
- Health insurance
Quick Apply
Manager, Clinical Research Finance Operations (Office of Clinical Research)
University of Pennsylvania —Philadelphia, PA
- $79,500 - $95,000 a year
- Full-time
- Hybrid work
- Background check
- 5 years
- Finance
- Health insurance
- Dental insurance

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Senior Clinical Trial Case Manager

CSL -
King of Prussia, PA

Apply Now

Job Details

Full-time
14 days ago

Qualifications

Quality control corrective actions
Biology
Bachelor's degree in biological science
Regulatory inspections
Incident reporting compliance
Healthcare incident report preparation
7 years
Clinical compliance checks
Adverse event reporting
Clinical research audit management
Preventive action implementation
Medical coding
Privacy law
Data reporting
Corrective and preventive actions (CAPA)
Master's degree
Clinical case management
Certified Ambulatory Perianesthesia Nurse
Vendor compliance management
Clinical staff training
Bachelor's degree
Data management
Doctor of Philosophy
Clinical training
Pharmaceutical company experience
Team training
Adverse drug reaction monitoring
Clinical program data analysis
Bachelor's degree in pharmaceutical sciences
Clinical data report preparation

Full 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.

Apply Now

Refine Your Search

clinical research manager jobs in philadelphia pa

Senior Clinical Trial Case Manager

Senior Manager, Clinical Operations - FSP Resource & Vendor Management

Clinical Research Project Manager C

Clinical Research Project Manager B

Clinical Research Project Manager B (Department of Obstetrics and Gynecology)

Clinical Research Project Manager

Clinical Research Program Manager

Clinical Data Manager

Clinical Research Project Manager A

Clinical Data Manager

Clinical Research Lead

Clinical Development Trial Lead

Clinical Project Lead, Oncology

Project Manager, Imaging and Cardiac

Clinical Operations Lead

Clinical Trial Lead

Research Project Manager A

Sr. Project Manager

Medical Operations Manager- Philadelphia, PA

Manager, Clinical Research Finance Operations (Office of Clinical Research)

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