Top 23998 Project Manager Clinical Jobs

Senior Clinical Trial Case Manager
CSL Behring —King of Prussia, PA
- Full-time
- 7 years
- Master's degree
- Bachelor's degree
Director of Research Operations and Administration
Children's Hospital Colorado —Aurora, CO
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- 403(b) matching
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Operations Manager
Cardiovascular Institute of San Diego —San Diego, CA
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Publication Manager I
Daiichi Sankyo —Basking Ridge, NJ
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Ambulatory Manager
COMPUNNEL INC —South San Francisco, CA
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Clinical Study Project Manager
IUVO BIOSCIENCE OPERATIONS, LLC —Remote
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Senior Clinical Project Manager
CG Oncology Inc —Remote
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- Bachelor's degree
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- Senior level
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Clinical Project Manager
Hematogenix Laboratory Sv —Tinley Park, IL
- Full-time
- Bachelor of Science
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- 2 years
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Clinical Trial Manager
Medilink Therapeutics —Remote
- $120,000 - $200,000 a year
- Full-time
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Clinical Project Manager
Sionna Therapeutics Inc —Waltham, MA
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- Full-time
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- 5 years
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Sr. Manager
BMS —Princeton, NJ
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Clinical Data Management Manager
Vforce Infotech —Edison, NJ
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3d
Patient Educator Senior Manager (WEST)
Vertex Pharmaceuticals —California
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- Weekends as needed
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Manager, Clinical Programming (Remote)
Penfield Search Partners —Fairfield, CT
- Contract
- Remote
- Computer Science
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3d
Senior Manager, Clinical Guidelines
American Academy of Dermatology —Rosemont, IL
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- 8 years
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Project Manager - Strategic Support
Family Health Centers of San Diego —San Diego, CA
- $80,000 - $120,000 a year
- Full-time
- Clean driving record
- Microsoft Excel
- Microsoft Outlook
- Paid holidays
- Health insurance
Quick Apply
Clinical Trials Fiscal Manager
Fred Hutchinson Cancer Center —Seattle, WA
- $109,699 - $173,347 a year
- Full-time
- Microsoft Word
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- Bachelor's degree
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10d
Manager Clinical Research
Baylor Scott & White Health —Dallas, TX
- Microsoft Excel
- Customer service
- BLS Certification
- Health insurance
- Tuition reimbursement
Research Project Mgr
Baylor Scott & White Health —Plano, TX
- Mid-level
- Master's degree
- Bachelor's degree
- Health insurance
- Tuition reimbursement
5d
Program Manager Magnet
Cooperman Barnabas Medical Center —Livingston, NJ
- $119,000 - $150,000 a year
- Full-time
- Nursing
- RN License
- Mid-level
- Paid parental leave
- Paid holidays

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Senior Clinical Trial Case Manager

CSL Behring -
King of Prussia, PA

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Job Details

Full-time

Qualifications

Quality control corrective actions
Biology
Bachelor's degree in biological science
Regulatory inspections
Incident reporting compliance
Healthcare incident report preparation
7 years
Data compliance
Pharmacovigilance research
Adverse event reporting
Preventive action implementation
Medical coding
Privacy law
Corrective and preventive actions (CAPA)
Master's degree
Clinical case management
Certified Ambulatory Perianesthesia Nurse
Vendor compliance management
Bachelor's degree
Data management
Doctor of Philosophy
Clinical training
Pharmaceutical company experience
Team training
Data reporting support
Bachelor's degree in pharmaceutical sciences
Clinical data report preparation
Vendor relationship management
Regulatory readiness in healthcare
Clinical trial standard operating procedures

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.

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

Project Manager Clinical jobs

Senior Clinical Trial Case Manager

Director of Research Operations and Administration

Operations Manager

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Clinical Study Project Manager

Senior Clinical Project Manager

Clinical Project Manager

Clinical Trial Manager

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Manager, Clinical Programming (Remote)

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Project Manager - Strategic Support

Clinical Trials Fiscal Manager

Manager Clinical Research

Research Project Mgr

Program Manager Magnet

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