The Associate Director, Clinical Operations is responsible for Oversight of the Project Management team, Clinical Research Associates, Clinical Trial Associates as well as motivating, mentoring and training. Associate Director, Clinical Operations . Oversee and manage all operational asp...
This position supports safety monitoring and risk management activities, provides insights on current clinical practice and guidelines, reviews and provides written assessments of relevant medical topics, and supports PV Operations' medical review function. More Years of clinical experience preferre...
Works collaboratively with clinical project managers, statistical programmers, clinical research associates, and others to meet project deliverables and timelines for clinical data acquisition, quality checking, and reporting. Head of Clinical Data Management. Main responsibilities will include effe...
Such trials could be pivotal for submission; Prepares clinical section of regulatory documents; Oversees management and performance of CRO; Participates in creation of developmental and regulatory strategy; Drafts protocol profiles and sections of key submission documents; Point of contact for inter...
Director, Clinical Development - Immunology. Meet has partnered with a well-established pharma based on the East Coast! They are looking for a Director of Clinical Development to join their immunology department. Ensure clinical trial compliance with clinical guidance, ICH, and GCP. This position wi...
Such trials could be pivotal for submission; Prepares clinical section of regulatory documents; Oversees management and performance of CRO; Participates in creation of developmental and regulatory strategy; Drafts protocol profiles and sections of key submission documents; Point of contact for inter...
The Principle Clinical Research Director (CRD) is noted as the primary clinical lead for complex. Provide appropriate medical input & support for all activities related to clinical studies such as medical training, feasibility, medical review of data, medical information for the study team, medical ...
Such trials could be pivotal for submission; Prepares clinical section of regulatory documents; Oversees management and performance of CRO; Participates in creation of developmental and regulatory strategy; Drafts protocol profiles and sections of key submission documents; Point of contact for inter...
The AD, Global Clinical Operations (GCO) Clinical Trial Operational Risk (CTOR), will be responsible for lifecycle management of GCO Risks and issues and ownership (design RM oversight tools, management, and maintenance), and provide day-to-day operational risk support to study teams and their line ...
The Associate Director, Clinical Data Standards, is responsible for the development, maintenance, and enforcement of data standards through extensive collaborations with Daiichi Sankyo's internal and external stakeholders. Leads implementation of Therapeutic level clinical data collection requiremen...
Provide appropriate medical input & clinical leadership for all activities related to study conduct such as responses to IRBs and HA questions, protocol scientific and medical training, medical review of data within the scope of the Centralized monitoring, clinical and medical information for the st...
WCG Clinical Director, Strategic Alliances (Remote) Princeton , New Jersey Apply Now. The Director, Strategic Alliances is responsible for supporting the Strategic Alliance Executives to create significant new business opportunities in WCG’s largest and most established accounts. Using so...
Responsible for all aspects of Clinical Pharmacology and Biopharmaceutics studies and model-based drug development plans, serves as QCP subteam leader / clinical pharmacology project team representative, supports Phase 2/3 clinical pharmacology objectives with high-level supervision, participates in...
Prepares/reviews key clinical documents such as: meeting requests and briefing packages for Regulatory agencies, extended synopsis/protocol for clinical trials, Investigator Brochure, Clinical Trial Authorization dossier (IMPD, IND), summary of clinical efficacy and clinical overview of the Common T...
As a passionate and experienced Clinical Manager looking to elevate your career to the next level, you’ll join Kaleidoscope ABA Therapy as a Regional Clinical Development Director and lead a team of dedicated BCBAs in creating a positive and transformative impact. Regional Clinical Development Direc...
The Associate Director, Clinical Imaging will own the strategy and execution of sophisticated early and late phase oncology imaging in clinical trials where imaging plays a meaningful role. We assume you will be an imaging scientific leader and a member of cross-functional program teams including Re...
The Director, Clinical Operations/CPM is responsible for the development of a Clinical Operations Team in the United States. Director, Clinical Operations/CPM. Team Mentoring, Motivating, Training and Oversight for a team of Project Managers, Clinical Research Associates (CRAs), Clinical Trial Assoc...
Provide all necessary leadership and guidance to keep the quality of clinical study-related documents (clinical study protocol (PRT), investigator’s brochure (IB), clinical study report (CSR), medical monitoring plan (MMP), safety management plan (SMP), informed consent form (ICF), clinical study da...
You will ensure that Agilent’s processes for clinical quality oversight of clinical trial conduct, clinical trial sites, and suppliers, as well as vigilance oversight of product quality issues are robust and in alignment with ICH E6, other applicable Good Clinical Practice (GCP) and Good Vigilance P...
Designs and develops clinical studies and research plans in support of asset strategy with the Early Clinical Development Leadership team; clinical studies include first-in-human Phase I, proof of concept Phase I/II, entry registrational studies, biomarker qualification studies, and/or clinical phar...
Join a Legacy of Innovation 110 Years and Counting!.Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology.Wi...
Works collaboratively with clinical project managers, statistical programmers, clinical research associates, and others to meet project deliverables and timelines for clinical data acquisition, quality checking, and reporting. Head of Clinical Data Management. Main responsibilities will include effe...
Occasional interactions with CRO senior leadership as needed; Participates in creation of developmental and regulatory strategy in collaboration with Regulatory Affairs; Drafts clinical development plans, protocol profiles and sections of key submission documents; Point of contact for interactions w...
The Director will work closely with senior management and our business development team to gain credibility with our clients by identifying and recommending innovative ways of delivering services to our clients by providing Resourcing Services, Consulting Services, Managed Services, and Learni...
Proclinical is seeking a dedicated and talented individual for the role of Clinical Quality Assurance, Director. Director Clinical Quality Assurance. This role involves designing and implementing efficient clinical trial protocols, managing compliance systems, and ensuring readiness for Good Clinica...