Top 18 clinical trial administrator Jobs in schwenksville pa

Senior Clinical Trial Case Manager
CSL Behring —King of Prussia, PA
- Full-time
- 7 years
- Master's degree
- Bachelor's degree
11d
Clinical Trial Associate
Avalo Therapeutics —Chesterbrook, PA
- Full-time
- Microsoft Outlook
- Mid-level
- Bachelor's degree
Quick Apply
Clinical Trial Associate
KPS Life —Malvern, PA
- Microsoft Excel
- 5 years
- Organizational skills
Clinical Trial Manager
Avalo Therapeutics —Chesterbrook, PA
- Hybrid work
- 5 years
- Office
- Bachelor's degree
Quick Apply
Principal Investigator (MD/DO) - Dermatology Clinical Trials
Hawthorne Health —Horsham, PA
- $250 an hour
- Part-time
- Hybrid work
- Medicine
- BC/BE
- English
Quick Apply
Principal Investigator (MD/DO) - Cardiology Clinical Trials
Hawthorne Health —Horsham, PA
- $250 an hour
- Part-time
- Hybrid work
- Medicine
- BC/BE
- English
Quick Apply
Principal Investigator (MD/DO) - Rheumatology Clinical Trials
Hawthorne Health —Horsham, PA
- $250 an hour
- Part-time
- Hybrid work
- Medicine
- English
- Patient care
Quick Apply
Senior Clinical Trial Manager
ICON Plc —Blue Bell, PA
- Full-time
- Management
- Bachelor of Science
- Writing skills
- Disability insurance
- Health insurance
Principal Investigator (MD/DO) - Respiratory Clinical Trials
Hawthorne Health —Horsham, PA
- $250 an hour
- Part-time
- Hybrid work
- Medicine
- English
- Pre-employment physical examination
Quick Apply

Other jobs to consider

Find your next job by exploring related positions.

Senior MRI Clinical Support Specialists
Immediate Healthcare Solutions —Philadelphia, PA
Associate degree in Radiologic Sciences or related field. *ARRT certification with current MRI credentials (or equivalent)*.
From $140,000 a year
Quick Apply
8d
Senior Data Validator, Clinical Oversight & Standards
CSL Behring —King of Prussia, PA
Serve as a subject matter expert in CDASH, SDTM mapping, and EDC systems, providing guidance on data standards, eCRF design, and validation approaches to…
$143,000 - $169,000 a year

Show more related jobs

Explore jobs in cities nearby

Check out jobs in cities near your current location, Columbus

Clinical Research Coordinator I - RI Behav Trials Off
Nationwide Children's Hospital —Columbus, OH
Recruits, consents and enrolls subjects according to ICH/GCP regulations, and subjects’ rights through institutional IRB, federal and state regulations; answers…
Senior Sales Manager- Clinical Trials
Cencora —Columbus, OH
Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic…
$88,700 - $126,940 a year

I want to receive the latest job alert for clinical trial administrator in schwenksville pa

By signing in to your account, you agree to SimplyHired's Terms of Service and consent to our Cookie and Privacy Policy.

Explore jobs in more locations

clinical trial administrator jobs near schwenksville pa

Clinical Trial Manager jobs in King Of Prussia, PA

Clinical Trial Manager jobs in Blue Bell, PA

Clinical Trial Administrator jobs in Denver, Co

Clinical Trial Administrator jobs in Raleigh, Nc

Clinical Trial Administrator jobs in Minnesota

Nursing Clinical Instructor jobs in Texas

Clinical Trial Administrator jobs in Radnor, Pa

Non Clinical Nursing jobs in Las Vegas, Nv

Clinical Trial Manager jobs in Arkansas

Dietary Manager jobs in Denver, Co

Clinical Trial Manager jobs in St. Louis, Mo

Clinical Trial Manager jobs in Maryland

Clinical Trial Manager jobs in Memphis, Tn

Case Manager jobs in Arizona

Clinical Pharmacist jobs in Pittsburgh, Pa

Clinical Trial Manager jobs in Queens, Ny

Housekeeping Manager jobs in Miami, Fl

Clinical Trial Manager jobs in Seattle, Wa

Clinical Documentation Specialist jobs in Cleveland, Oh

Clinical Trial Manager jobs in Irvine, Ca

Senior Clinical Trial Case Manager

CSL Behring -
King of Prussia, PA

Apply Now

Job Details

Full-time
11 days ago

Qualifications

Quality control corrective actions
Standard Operating Procedures (SOPs) implementation
Privacy law
Corrective and preventive actions (CAPA)
Policy & process development
Pharmaceutical company experience
Managing projects
Clinical quality assurance standards
Standard operating procedures (SOPs)
Standard operating procedures drafting

Full Job Description

Responsibilities: • Leads or plays a key role in cross-functional teams for the review of safety data or safety-related reports • Mentors and trains newer members of the functional area • Ensures functions to comply with national and international regulations, such as GxP guidelines and/or any other relevant international and national legislation(s), regulations(s), and guidance(s) as well as company policies and procedures in area of responsibility • Ensures direct reports to support and ensure QPPV’s oversight on the company’s Pharmacovigilance system, and identify, implement and monitor KPIs/KQIs across the company and manages cross functional CAPAs and other improvement activities on behalf of the QPPV. • Performs impact assessment of evolving pharmacovigilance legislations and propose or provide strategic direction for implementation of required changes to the global PV system. This may involve cross-functional approaches, including multiple interface functions. • Supports the preparation and conduct of PV and other GxP inspections and audits, as required and organize or support the back-office for regulatory PV inspections. • Maintain/contribute to regulatory required documents such as the PSMF, in line with international and national regulations, guidelines and internal standards. • Implements and supervise pharmacovigilance procedures as well as processes and ensures the uniform and timely processing and analysis of safety data to comply with regulatory requirements • Ensure correct coding of all event and drug terms. • Ensure inter- and intra-consistency for case evaluations. • Participate in ICSR reporting compliance analysis and respective CAPA • Together with Risk Management function develops and maintains Medical Concepts to support internal decision making and safety analyses for safety surveillance and provides expertise to pharmacovigilance and clinical development programs with regards to safety data/ SAE coding • Manages regular MedDRA upgrades and provides impact analysis to RM physicians and ME • Develop and provide advanced analytical outputs to global teams to support analyses and decision making based on safety data. • Development of new or enhancement of existing standard reports per company BT quality standards • Gathers, details, and documents user requirements in a way that is useful and meaningful to their business area experts and the technical team implementing the solution • Analyzes impact from changes to the database or change in user/reporting requirements • Acts as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements. • Assists in the preparation of new drug application safety updates, investigational new drug safety reports, investigator communications, product labeling/package inserts and other reports as necessary. • May support/contribute to cross functional BT projects to fulfill GxP requirements and to improve inspection readiness • May support risk management operations, including ongoing review of literature and compilation and interpretation of safety data to support product strategies Qualifications: • Bachelor degree or equivalent in a life science discipline (e.g. nursing, biological, or pharmaceutical sciences), Medical Documentation, Master’s or PhD in life sciences. • 7+ years' Pharmacovigilance experience in multinational pharmaceutical industry. • Expert knowledge of local/international regulations and PV processes. • Knowledge of local/international relevant GxP regulations, IT standards and other relevant legislations such as legislations related to privacy protection. • Experience with regulatory inspections. • Experience in administration of complex data sets. • Experience in project-managing CAPA and SOP development. • Experience with relevant software applications. • Experience with GxP. Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.

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

clinical trial administrator jobs in schwenksville pa

Senior Clinical Trial Case Manager

Clinical Trial Associate

Clinical Trial Associate

Clinical Trial Manager

Principal Investigator (MD/DO) - Dermatology Clinical Trials

Principal Investigator (MD/DO) - Cardiology Clinical Trials

Principal Investigator (MD/DO) - Rheumatology Clinical Trials

Senior Clinical Trial Manager

Principal Investigator (MD/DO) - Respiratory Clinical Trials

Other jobs to consider

Explore jobs in cities nearby

I want to receive the latest job alert for clinical trial administrator in schwenksville pa

Explore jobs in more locations

About CSL Behring

Job Seeker Tools

Employer Tools

Browse

Stay Connected