Top 94 Clinical study manager Jobs in Warren Nj

Contract, Clinical Trial Associate
PTC Therapeutics, Inc. —Warren, NJ
- $35 - $47 an hour
- Full-time
- Microsoft Word
- Microsoft Excel
- Mid-level
Quick Apply
Director, Risk Based Quality Management (RBQM)
Daiichi Sankyo, Inc. —Basking Ridge, NJ
- $201,840 - $302,760 a year
- Hybrid work
- Master's degree
- Bachelor's degree
- Travel
Clinical Trial Manager
Genmab —Princeton, NJ
- $119,120 - $178,680 a year
- Online Application
- 5 years
- Master's degree
- Bachelor's degree
- Commuter assistance
- Paid parental leave
Associate Director - External Data Acquisition Lead (EDAL)
Genmab —Plainsboro, NJ
- $157,360 - $236,040 a year
- Online Application
- Master's degree
- Bachelor's degree
- Mentoring
- Commuter assistance
- Paid parental leave
Senior Manager, Clinical Programming
Genmab —Princeton, NJ
- $131,040 - $196,560 a year
- Online Application
- Computer science
- 6 years
- Computer Science
- Commuter assistance
- Paid parental leave
Director, Clinical Operations - AAV
Rocket Pharmaceuticals —Cranbury, NJ
- $196,000 - $294,000 a year
- Full-time
- Microsoft Outlook
- 8 years
- Bachelor's degree
- Paid holidays
- Health insurance
Global Project Head, Solid Tumor Immuno-Oncology
Sanofi EU —Morristown, NJ
- $232,500.00 - $335,833.33 a year
- Medicine
- 7 years
- Doctor of Philosophy
- Parental leave
Director, Strategic Clinical Vendor Oversight and Relationship Lead (CRO)
Genmab —Princeton, NJ
- $193,280 - $289,920 a year
- Online Application
- 8 years
- Bachelor's degree
- Training & development
- Commuter assistance
- Paid parental leave
Global Project Head, Solid Tumor Antibody Drug Conjugates (ADCs)
Sanofi EU —Morristown, NJ
- $232,500.00 - $335,833.33 a year
- Medicine
- 7 years
- Doctor of Philosophy
- Parental leave
Clinical Data Management Manager
Vforce Infotech —Edison, NJ
- $60,000 - $65,000 a year
- Full-time
- Nursing
- HIPAA
- Mid-level
Quick Apply
8d
Clinical Trial Assistant
Biotrial, Inc. —Newark, NJ
- $65,000 - $80,000 a year
- Full-time
- Writing skills
- Mid-level
- Office
- Health insurance
- Dental insurance
Quick Apply
9d
Sr Clinical Study Assoc CO
Daiichi Sankyo, Inc. —Basking Ridge, NJ
- $100,960 - $151,440 a year
- Office
- Bachelor's degree
- Travel
Student Assistant, Part Time (Multiple Vacancies)
Rutgers University —Piscataway, NJ
- $15.92 - $150.00 a day
- Part-time
- Psychiatry
- Databases
- University
- Paid holidays
- Dental insurance
Clinical Research Coordinator I
SGS —Union, NJ
- $22 - $23 an hour
- Full-time
- Computer literacy
- Basic math
- High school diploma or GED
- Health insurance
- Dental insurance
Quick Apply
Research Coordinator
Rutgers University —Newark, NJ
- $71,162 a year
- Full-time
- Mid-level
- Master's degree
- Analysis skills
- Paid holidays
- Dental insurance
Clinical Program Manager
Kite Pharma —Parsippany-Troy Hills, NJ
- $165,495 - $235,620 a year
- Full-time
- Master's degree
- Bachelor's degree
- Doctor of Philosophy
- Health insurance
- Dental insurance
Study Project Manager I - Hybrid
AbbVie —Florham Park, NJ
- $109,500 - $208,500 a year
- Full-time
- Hybrid work
- 6 years
- Bachelor's degree
- Experience equivalent to degree accepted
- Paid holidays
- Health insurance
2d
Clinical Research Associate
Rutgers University —Newark, NJ
- $68,147 a year
- Full-time
- HIPAA
- Mid-level
- Office
- Paid holidays
- Dental insurance
Sr. Study Manager, Clinical Operations
Taiho Oncology, Inc. —Princeton, NJ
- $166,600 - $196,000 a year
- Full-time
- Hybrid work
- Bachelor's degree
- Continuous improvement
- Contracts
- Paid time off
- Parental leave
Quick Apply
Senior Clinical Trials Management Associate
Kite Pharma —Parsippany-Troy Hills, NJ
- $115,260 - $164,120 a year
- Full-time
- Nursing
- Bachelor of Science
- Data analysis skills
- Health insurance
- Dental insurance

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Contract, Clinical Trial Associate

PTC Therapeutics, Inc. -
Warren, NJ

Quick Apply

Job Details

Full-time
$35 - $47 an hour

Qualifications

Microsoft Word
Microsoft Excel
Word embeddings
ICH guidelines
Bachelor's degree
Pharmaceutical company experience
Clinical quality assurance standards
Cross-functional collaboration
Cross-functional communication

Full Job Description

PTC Therapeutics is a global commercial biopharmaceutical company. For over 25 years our team has been deeply committed to a unified purpose: Extending life’s moments for children and adults living with a rare disease.

At PTC, we cultivate an inclusive culture where everyone feels valued, respected, and empowered. We welcome candidates from all backgrounds to join our team, fostering a strong sense of belonging.

Visit our website to learn more about our company and culture!
Site: www.ptcbio.com

Job Description Summary:

The Contract, Clinical Trial Associate provides clinical study and Trial Master File (TMF) support for clinical operations. This involves supporting Clinical Trial Managers (CTMs) with activities related to: study start-up; investigator site feasibility and selection; essential document review related to investigator site initiation and investigational product release and patient enrollment. This position may also provide support in project team meetings by capturing meeting minutes/action items and following up with action item owners to ensure tasks are completed.

The incumbent is also responsible for contributing to study budget management. This includes the review of vendor invoices for accuracy against budget, tracking vendor payments.

The incumbent works cross-functionally with internal departments and external resources on Clinical Development related issues.

The Contract, Clinical Trial Associate supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.
.

Job Description:

ESSENTIAL FUNCTIONS

Primary duties/responsibilities:

Facilitates clinical document management activities. This includes, but may not be limited to:
- Ensures the proper application of regulatory requirements pertaining to the management of clinical documents.
- Ensures electronic trial master files (eTMF) are compliant with relevant regulatory requirements by performing periodic and ad hoc reviews/audits of TMF. This includes the reconciliation of the TMF at study close-out.
- Responds to TMF-related inquiries and resolves issues within stipulated timelines.
- Performs quality checks of TMF-related documents, including clinical study site documents, email correspondence, training materials, and other related study documents.
- Applies ICH guidelines to generate filing indices.
- Maintains current lists of correspondence.
- Contributes to health authority inspection readiness by providing requested documents, from the TMF.
- Liaises with Contract Research Organization (CRO) to ensure study-related documents are delivered to the sponsor in a timely and compliant manner.
Supports CTMs with activities related to: study start-up; investigator site feasibility and selection; essential document review related to investigator site initiation and investigational product release and patient enrollment.
Assists CTMs with the oversight of CRO(s) and other study-related, third-party vendors to ensure study requirements are met.
Assists with preparing, editing, producing, tracking and routing clinical documents as required. This includes, but may not limited to, clinical protocols. Investigator Brochures and informed consents.
Assists with the review of monitoring visit reports.
Prepares and manages clinical study conduct binders that include meeting agendas, minutes, status or patient trackers, patient screening logs and other documents as appropriate.
Reviews vendor invoices for accuracy against budget and liaises with Finance as required to resolve issues, ensure payments are made, etc. Applies understanding of clinical contract terms.
Performs other tasks and assignments as needed and specified by management.

KNOWLEDGE/SKILLS/ABILITIES REQUIRED

Minimum level of education and years of relevant work experience.
Bachelor’s degree in a relevant life science or healthcare-related discipline and minimum 2 years of clinical research support experience in a pharmaceutical, biotechnology, or related environment.

Special knowledge or skills needed and/or licenses or certificates required.
Familiarity with clinical trial study documents.
Knowledge of Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines.
Proficiency with Microsoft Word and Excel.
Excellent verbal and written communication and skills.
Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.

Special knowledge or skills and/or licenses or certificates preferred.
Experience with TMFs. Performing periodic ad hoc, interim and end-of-study reviews/audits on paper and electronic TMFs for several trials to ensure TMF meets sponsor’s expectations (includes TMF reconciliation at study close-out)
Experience interacting with CROs. Performing TMF QC for Contract Research Organization (CRO) TMF and ensuring quality of the TMF.
Experience with Microsoft PowerPoint.

Travel requirements
10%

Expected Hourly Range:

$35 - $47/hour. The hourly salary offered will be contingent on assessment of the candidate's education level, background, and experience relative to the requirements of the position they are being considered for, as well as review of internal equity.

EEO Statement:

PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.

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clinical study manager jobs in warren nj

Contract, Clinical Trial Associate

Director, Risk Based Quality Management (RBQM)

Clinical Trial Manager

Associate Director - External Data Acquisition Lead (EDAL)

Senior Manager, Clinical Programming

Director, Clinical Operations - AAV

Global Project Head, Solid Tumor Immuno-Oncology

Director, Strategic Clinical Vendor Oversight and Relationship Lead (CRO)

Global Project Head, Solid Tumor Antibody Drug Conjugates (ADCs)

Clinical Data Management Manager

Clinical Trial Assistant

Sr Clinical Study Assoc CO

Student Assistant, Part Time (Multiple Vacancies)

Clinical Research Coordinator I

Research Coordinator

Clinical Program Manager

Study Project Manager I - Hybrid

Clinical Research Associate

Sr. Study Manager, Clinical Operations

Senior Clinical Trials Management Associate

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