Integrated Study Timeline Manager

Parexel has new opportunities for home-based Study Start Up Leaders to join our global team. Global experience is preferred, but not required.The Study Start-Up Leader is accountable for the execution of the study start-up strategy and planning, including the management and coordination of start-up activities such as alignment to country regulations,...

Parexel has new opportunities for home-based Study Start Up Leaders to join our global team. Global experience is preferred,The Study Start-Up Leader is accountable for the execution of the study start-up strategy and planning, including the management and coordination of start-up activities such as alignment to country regulations, Core/Site document...

SSM- Research Collaboration- Center of ExcellenceThe Senior Study Manager (SSM) leads and manages the tactical execution of one or more clinical studies of moderate complexity from study startup through database release and inspection readiness to ensure timely delivery of quality study dataRC COE Focus:Provide strategic advice and expertise on potential...

The TMF Study Owner provides pivotal support and subject matter expertise (SME) at a study level, proactively ensuring our clients' Trial Master Files (TMFs) are achieving an inspection ready state. They are an integral part of the study team, becoming a single point of contact to help maintain TMF health,consistency, and compliance across clinical trials...

The TMF Study Administrator provides expert support and analysis of the TMF, based on established procedures, to help maintain the inspection readiness of our clients' Trial Master File (TMF). They are key members of the team, promoting TMF health and best practices, while supporting senior members of the team with completing assigned tasks.Key...

The Investigator Contracts Lead is responsible for direct site facing contract and budget negotiations through contract execution with assigned clinical investigator sites including initial agreements and amendments and oversight of other contracting professionals on assigned studies. This also includes managing the Per-Subject Cost (PSC) process for...

Parexel is hiring an Investigator Contracts Lead I for a 4 month contract.Job Summary:Investigator Contracts Lead I (ICL I) is responsible for direct site facing contract and budget negotiations through contract execution with assigned clinical investigator sites including initial agreements and amendments and oversight of other contracting professionals on...

Remote position- any Location US or Canada.Job Summary:Investigator Contracts Lead I (ICL I) is responsible for direct site facing contract and budget negotiations through contract execution with assigned clinical investigator sites including initial agreements and amendments and oversight of other contracting professionals on assigned studies. This also...

Job Purpose:The Site Monitor II (SM II) will be responsible for data integrity, data quality and ensuring compliance with International Conference on Harmonization and Good Clinical Practice (ICH-GCP) and local requirements at the site level. Monitoring will be conducted in line with the Study Monitoring Plan (SMP) and will be performed virtually for the...

The Senior Clinical Research Associate (SrCRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local study team(s). The SrCRA works in close collaboration with other CRAs and the Local Study Team/ Local Study Associate Director (LSAD) to ensure that study commitments are achieved in a timely and...

Parexel FSP is looking for a CRA in the MidWest, Northeast and Southeast area of the United StatesJob Purpose: The Clinical Research Associate (CRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local study team(s). The CRA works in close collaboration with other CRAs and the Local Study Team/...

The Initiation Clinical Research Associate II (iCRA) specializes in Pre SIV activities will be assigned & accountable for managing and driving the strategy for the Pre SIV / start up tasks of the study. The iCRA can also support protocol amendments if applicable. Site Management experience or equivalent experience in clinical research, with understanding of...

Critical R&D clinical trial 3rd party supplier contract (SOW, Change Order) management (review, execution) Management of Project Resource Evaluation Process. Leverage the clinical partner management process to ensure adherence, management and oversight of the supplier selection and approval process. Work collaboratively with cross-functional teams to ensure...

Job Summary:The Senior Clinical Contract Analyst serves as a conduit between Clinical Operations and the Legal group for contract requests including Confidentiality Agreements, Clinical Trial Agreements (CTAs), Ancillary Services Agreements, Consultant Agreements and other clinical contracts.Primary Duties:Manage Clinical Contract and Nondisclosure Agreement...

Acts as the primary point of contact with the CMO project management team to communicate trial supply requirements, initiate quotes and develop supply delivery timelines in conjunction with the CMO. The Clinical Supply Program Manager (CSPM) partners with Global Clinical Supply Chain (GCSC), Clinical Operations, Quality, External Vendors and other key...

Parexel is known for our unparalleled expertise in DermatologyOver the past five years Parexel has provided clinical research services for ~100 dermatology studies, enrolling more than 20,000 patients at ~5,000 hospitals and clinics worldwide. We play an integral role in bringing new treatment options to millions of patients globally In fact, as one example,...

This Process Pillar Lead role within Process Development and Delivery will manage activities for the Clinical Trial Delivery Quality Management System (QMS) Standard Operating Procedure (SOP) development and maintenance in partnership with R&D Quality Assurance (QA). This includes cross-functional collaboration with stakeholders and functional leaders across...

Parexel's Clinical Neurosciences (CNS) Team is hiringWorking at Parexel's Medical Sciences team is about enhancing your understanding of diseases and the drug development process. It's about learning from colleagues with multiple specializations and with experience of how practices vary in different countries. You proudly share your knowledge to grow...

Position Overview: The Nursing Operations Manager will play a pivotal role in delivering patient-centered care. Collaborating closely with the interdisciplinary team, this position focuses on enhancing clinical efficiency, managing equipment and inventory, and overseeing the recruitment and training of medical support personnel. Key Responsibilities:...

Home Based, USAs a Site Contract Lead you will oversee the site contracting process for clinical trials, ensuring that contracts are executed in a timely and effective manner. This is a client facing role with both sponsors and team projects.Accountabilities:Monitor, drive, and report on site contract performance throughout the whole lifecycle, specifically...