Current jobs related to Senior Specialist, Clinical Trial Associate - Warren - PTC Therapeutics
-
Clinical Exercise Specialist
7 days ago
Warren, United States Woods Cardiovascular Internal Full timePosition OverviewWe are seeking a dedicated Clinical Exercise Specialist to enhance the fitness and health outcomes of our clients. In this role, you will be primarily engaged in the Stress Testing department.As a Clinical Exercise Specialist, your responsibilities will include conducting various exercise and pharmacologic stress assessments. Depending on...
-
Senior Patient Access Specialist
2 months ago
Warren, United States Ensemble Health Partners Full timeEnsemble Health Partners LLC Senior Patient Access Specialist Warren , Ohio Apply Now Thank you for considering a career at Ensemble Health Partners! EARLY LEVEL CAREER OPPORTUNITY OFFERING: Bonus Incentives Paid Certifications Tuition Reimbursement Ensemble Health Partners is a leading provider of technology-enabled revenue cycle management solutions for...
-
Senior Patient Access Specialist
1 month ago
Warren, United States Ensemble Health Partners Full timeThank you for considering a career at Ensemble Health Partners! Ensemble Health Partners is a leading provider of technology-enabled revenue cycle management solutions for health systems, including hospitals and affiliated physician groups. They offer end-to-end revenue cycle solutions as well as a comprehensive suite of point solutions to clients across the...
-
Clinical Nurse Specialist
7 days ago
Warren, United States Autumn Woods Health Care Full timeJoin Our Team as a Clinical Nurse SpecialistAt Autumn Woods Health Care, we are thrilled to welcome applications for the position of Clinical Nurse Specialist (CNS). This role is essential in delivering comprehensive nursing care to our residents within a skilled nursing environment.What We Offer:We prioritize the well-being of our employees, ensuring a...
-
Clinical Nurse Specialist
1 week ago
Warren, United States Autumn Woods Health Care Full timeJoin Our Team as a Clinical Nurse SpecialistAt Autumn Woods Health Care, we are thrilled to announce our collaboration with MediLodge, enhancing our commitment to quality care. We are currently seeking a dedicated Clinical Nurse Specialist (CNS) to become an integral part of our team.Discover the opportunities that a career at Autumn Woods can offer you. Our...
-
Senior Procurement Specialist
7 days ago
Warren, United States STREET LEGAL INDUSTRIES INC Full timeJob OverviewPosition Summary:The selected candidate will function as a senior procurement specialist and a technical authority on acquisition-related issues within the designated organization. This role requires maintaining a thorough understanding of all operations and elements associated with the designated acquisition program(s), including pertinent...
-
Senior Procurement Specialist
7 days ago
Warren, United States STREET LEGAL INDUSTRIES INC Full timeJob OverviewPosition Summary:The selected candidate will function as a senior procurement specialist and a technical authority on acquisition-related issues within the designated organization. This role demands a comprehensive understanding of all functions and elements associated with the designated acquisition program(s), including pertinent Government...
-
Senior Research Associate
2 weeks ago
Warren, United States Net2Source Inc. Full timeNet2Source Inc. is an award-winning total workforce solutions company recognized by Staffing Industry Analysts for our accelerated growth of 300% in the last 3 years with over 5500+ employees globally, with over 30+ locations in the US and global operations in 32 countries. We believe in providing staffing solutions to address the current talent gap –...
-
Senior Research Associate.
2 weeks ago
Warren, United States TSR Consulting Services, Inc. Full time80319TSR is a premier National U.S. Staffing company with over 50 years of staffing excellence.Our client, a leading pharmaceutical company is hiring a Senior Research Associate. Please ONLY local candidates to Warren NJ. Flex is required as needed for extended hours or weekends based on needs of the business.Successful candidates will have a very strong...
-
Senior Research Associate.
3 days ago
warren, United States TSR Consulting Services, Inc. Full time80319TSR is a premier National U.S. Staffing company with over 50 years of staffing excellence.Our client, a leading pharmaceutical company is hiring a Senior Research Associate. Please ONLY local candidates to Warren NJ. Flex is required as needed for extended hours or weekends based on needs of the business.Successful candidates will have a very strong...
-
Clinical Laboratory Specialist
7 days ago
Warren, MI, United States Food Management Search Full timePosition Overview: We are seeking a dedicated Clinical Laboratory Specialist to join our team. This role is essential in ensuring the accuracy and reliability of laboratory testing, contributing to high-quality patient care.Job Details:Location: Not specifiedSchedule: 4 shifts of 10 hours with rotating weekends, typically from 8:30 PM to 7 AM.Duration: This...
-
QA Specialist
1 month ago
Warren, United States Integrated Resources, Inc (IRI) Full timeJob Description: Quality SpecialistSpecialist, QA Operations, is responsible for quality oversight of Cell Therapy Development Operations (CTDO) activities in accordance with Client policies, standards, procedures, and Global cGMP requirements.This position reports to the Senior Manager of Quality Assurance Operations.Label Printing and Issuance of finished...
-
QA Specialist
1 month ago
Warren, United States Integrated Resources, Inc (IRI) Full timeJob Description: Quality SpecialistSpecialist, QA Operations, is responsible for quality oversight of Cell Therapy Development Operations (CTDO) activities in accordance with Client policies, standards, procedures, and Global cGMP requirements.This position reports to the Senior Manager of Quality Assurance Operations.Label Printing and Issuance of finished...
-
Clinical Engineering IT Specialist
7 days ago
Warren, Michigan, United States TriMedx Full timeAbout TRIMEDXAt TRIMEDX, our associates are united by a shared mission to provide exceptional service to clients, patients, and communities. We prioritize collaboration and support, fostering an environment where every associate is valued and contributes to our collective success.Position OverviewThe Clinical Engineering IT Technician plays a crucial role in...
-
Senior Patient Access Specialist
1 day ago
Warren, United States Ensemble Health Partners Full timeAbout the Role:We are seeking a highly skilled Senior Patient Access Specialist to join our team at Ensemble Health Partners, a leading provider of technology-enabled revenue cycle management solutions for health systems. As a Senior Patient Access Specialist, you will be responsible for performing admitting duties for all patients admitted for services at...
-
Culinary Specialist for Senior Living
7 days ago
Warren, United States OMNI MANOR INC Full timePosition OverviewAs a Culinary Specialist at OMNI MANOR INC, you will be responsible for the preparation and cooking of meals tailored to the dietary needs of our residents. Your role will also involve overseeing the activities of staff members who assist in meal preparation and service.Key Responsibilities:Prepare and cook nutritious meals for...
-
Senior Manager, Quality Assurance
3 weeks ago
Warren, United States PTC Therapeutics Full timeJob Description Summary: The Senior Manager, Quality Assurance - GxP (GCP) is responsible for managing GxP Quality Assurance (QA) functions with an emphasis on Good Clinical Practice (GCP) compliance for development products. This involves engaging and collaborating with cross-functional internal and external teams to evaluate processes, procedures, and...
-
Culinary Specialist for Senior Living
1 week ago
Warren, United States OMNI MANOR INC Full timePosition OverviewAs a Culinary Specialist at OMNI MANOR INC, you will be responsible for preparing and cooking nutritious meals tailored to the dietary needs of our residents. You will also oversee the activities of staff members who assist in meal preparation and service.Key Responsibilities:Prepare and cook meals that meet the dietary requirements of...
-
Culinary Specialist for Senior Living
7 days ago
Warren, United States OMNI MANOR INC Full timePosition OverviewAs a Culinary Specialist at OMNI MANOR INC, you will be responsible for preparing and cooking nutritious meals tailored to the dietary needs of our residents. You will also oversee the activities of staff members who assist in meal preparation and service.Key Responsibilities:Prepare and cook meals that meet the dietary requirements of...
-
Clinical Laboratory Specialist
1 week ago
Warren, United States IASIS Healthcare Full timePosition Overview:As a Clinical Laboratory Specialist, you will play a crucial role in supporting the mission and values of IASIS Healthcare. Your primary responsibility will be to perform a variety of laboratory tests, ensuring accuracy and timely results that contribute to patient care.Key Responsibilities:Conduct a range of laboratory tests, from simple...
![PTC Therapeutics](https://media.trabajo.org/img/noimg.jpg)
Senior Specialist, Clinical Trial Associate
2 months ago
The Senior Specialist, 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 Senior Specialist, 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 development and production of presentations, reports, submissions, articles, and other materials.
- 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.
* Minimum level of education and years of relevant work experience.
- Bachelor's degree in a relevant life science or healthcare-related discipline and minimum 4 years of clinical research support experience in a pharmaceutical, biotechnology, or related environment or a recognized equivalent of education and experience.
- 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.
- 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.
- 10%
#LI-NM1
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.
Click here to return to the careers page