Clinical Quality Agreement life cycle; lead the creation of the Clinical Quality Agreement; lead the conduct of cross... with worldwide regulatory requirements; providing relevant and constructive evaluation of Clinical external suppliers that provide...
sampling, home visit options etc. In conjunction with project lead, supp: Develop and reviewing study documents...Services Overview: This job is part of our change and innovation team seeking to optimize clinical trials. This role...
possible safety issues to AD Pharmacovigilance and Clinical/Medical Monitor as needed for assigned product(s) Define search criteria... (e.g., PT, SMQs), run validated database searches, and analyze data for safety signal detection Collaborate with PV lead...
development and complex clinical trials, including IDE approvals and EU Performance Study Application submissions Experience... for high-complexity diagnostics specifically Companion Diagnostics and digital pathology in the clinical oncology environment...
campaign performance throughout enrollment. ACCOUNTABILITIES Post strategy development, lead study-specific recruitment... programs working with the PR&R leads clinical study teams, vendors, and CRO as applicable. Work with PR&R specialist...
. d. Lead, facilitate and/or participate in Quality Management and other process improvement teams as assigned. e. Actively... Laboratory Sciences, Clinical Laboratory Sciences, Biology, Chemistry, or relevant degree. MINIMUM EXPERIENCE: Five years...
for investigator-initiated and sponsor-funded clinical trials. Serve as a strategic advisor to Principal Investigators (PIs), study... Responsibilities Lead the development and execution of comprehensive, protocol-specific recruitment and retention strategies...
Local Study Associate Director ICON plc is a world-leading healthcare intelligence and clinical research organization..., and we welcome you to join us on our mission to shape the future of clinical development What you will be doing: Has the overall responsibility for the study...
for drugs and biologics. Familiarity with GLP/GCP/GMP, clinical laboratory regulations, and licensing. Experience in various... regulatory submissions and communication with regulatory agencies. Hosted communication with the agencies on clinical development...
health outcomes, we serve humanity when we: Lead with Science, Anchor in Pragmatism: We pioneer life-changing science... of the journey. About The Role The Program Director will lead cross-functional teams in the development and validation...
in a related field. Previous Pharma/Life Science/Biotech/Clinical Study/CRO experience. Very strong technical skills and ability...: Serve as lead Finance Business Partner for early and late-Stage Alliances. Responsibilities include end-to-end financial...
We are seeking a Senior Clinical Site Lead to join a dynamic team working within the client environment. The...-level clinical study conduct JOB SPECIFIC COMPETENCIES & SKILLS Strong communication skills (verbal, written...
state awareness, clinical and economic data generation, pricing strategies, new product development, reimbursement..., reviewing production and sales costs, anticipating volume, and costing special and customized orders. When appropriate, lead...
/ clinical regulatory strategy and plan in alignment the overall clinical development plan. This team will take a lead role... milestones. Summary Description: The Reg Nonclinical / Clinical Associate Director will lead, conceive, communicate...
-regional Regulatory Submission Teams. Participates on other Sub-teams (e.g., Study Management, Clinical, Nonclinical... Regulatory Lead on the assigned products, compounds, indications or projects in Virology. With guidance, you will define the...
statistical consultation on clinical development plans, clinical trial design and clinical study endpoints, calculating sample... Responsibilities: With guidance, acts as biostatistics lead on clinical studies or other non-molecule projects. Where applicable...
expectations for all phase study type awards, and rescue and feasibility only opportunities; includes leading mid-level... (unit tracking/percent completes, resourcing projections); discusses contingency plans with strategist and/or Clinical...
, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies. If you're... downstream issues and contribute to large-scale process investigations. Manage operational details such as long-lead material...
and approval, subject recruitment, appropriate study testing, and adequate enrollment of all multicenter clinical trials... including regulatory and compliance responsibilities. Three to 5 years in a Lead or Supervisory role. Clinical Trial...
to, and/or tracks non-clinical patient complaints. Informs Practice Manager of changes or problems within the practice. Maintains... in a multi-specialty physician practice setting. Supports the Practice Manager in the daily administrative operations of the...