- Taiho Oncology (Princeton, NJ)
- … operations practices and processes ensuring consistent delivery across studies . Education/Certification Requirements: + Associate 's degree or equivalent. ... impactful results. The leadership and support provided by our Clinical Operations team are the cornerstone of...dynamic team cultivating growth and learning. Position Summary: The Study Associate (SA) I is responsible for… more
- Sumitomo Pharma (Trenton, NJ)
- …Trial Master Files (TMFs) ready for audits and inspections. Partnering with the Associate Director, Clinical Business Operations , the specialist ensures ... and system work instructions. Provide support and guidance to study team members during the full lifecycle of the...ensure system validation is maintained. + Work closely with Clinical Operations and Regulatory Affairs to ensure… more
- Merck (Rahway, NJ)
- …Practice (GLP) studies . The Associate Principal Scientist is the primary clinical study team leader and has overall responsibility for a study . ... and organization of paper and Electronic Data Capture (EDC) clinical studies that meet scientific and regulatory...Sciences, Clinical Site Management, Clinical Study Design, Clinical Trials Operations ,… more
- Parexel (Trenton, NJ)
- …or Director of Site Management and Monitoring (DSMM) + Partners with SCP and Country Study Operations Manager (SOM) + When required Partners with other Study ... **Job Purpose:** The Senior Clinical Research Associate (Sr. CRA) is...Demonstrated knowledge in disease and technical areas pertaining to clinical studies , including knowledge of company direction,… more
- Sumitomo Pharma (Trenton, NJ)
- …director is responsible for the leadership, development, and management of clinical studies while building and maintaining relationships with investigators ... highly motivated, and experienced individual for the position of ** Associate ** **Medical Director, Clinical Development - Oncology**...and study staff. + Responsible for leading clinical study teams, monitoring overall study… more
- Organon & Co. (Jersey City, NJ)
- …to support efficient, on-time execution of clinical studies and early clinical study operations . + Actively facilitate (and escalation as necessary) ... experience in pharmaceutical research and development. + Knowledgeable of clinical operations and study management,...Knowledgeable of clinical operations and study management, and outcomes research studies for… more
- AbbVie (Florham Park, NJ)
- …YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Associate Director, Statistics provides statistical leadership for clinical ... of methodologies for confounding control and bias minimization in observational studies preferred. Key Stakeholders Clinical development experts Statistical… more
- AbbVie (Florham Park, NJ)
- …YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Associate Director, Statistics - Immunology provides statistical leadership for ... clinical development and life-cycle management strategies for assigned projects....trials, patient safety, and global medical affairs (GMA). The Associate Director works in partnership with experts in multiple… more
- Sumitomo Pharma (Trenton, NJ)
- …relationships with colleagues, fostering collaboration, and idea sharing + Reviews nonclinical, clinical and CMC documentation (eg nonclinical study reports, ... general product development in the pharmaceutical industry + Experience reviewing nonclinical, clinical and CMC documentation (eg nonclinical study reports, … more
- Parexel (Trenton, NJ)
- …of clinical trial samples + Provides support for sample related matters to clinical study teams + Works with Informed Consent Form (ICF) Specialist and ... clinical trials. Performs other duties as necessary to ensure optimal clinical trial execution. **Key Accountabilities** **:** ** Study Team Support** +… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …maintain the effectiveness of the Otsuka Quality Systems that support OPDC-sponsored clinical studies as well as drive continuous improvement. **Job ... release process for OAPI GMP release of Contract Manufacturers operations supporting clinical and commercial products. +...escalation of any situations with potential negative impacts on clinical study supplies, supply chain for commercial… more
- Ascendis Pharma (Princeton, NJ)
- …groups. + Work with internal stakeholders including Commercial, Legal, Regulatory, Clinical Development, Clinical Operations , Compliance, Pharmacovigilance, ... member of the Endocrine Medical Sciences team for the US business, the Associate Medical Director supports the US Medical Director for deliverables and activities… more
- J&J Family of Companies (Raritan, NJ)
- …Skills:** Analytical Reasoning, Clinical Research and Regulations, Clinical Trials Operations , Communication, Content Evaluation, Developing Others, ... at https://www.jnj.com/innovative-medicine We are searching for the best talent for the Associate Director, Global Medical Affairs Strategy & Execution to be in… more
- Sanofi Group (Morristown, NJ)
- …ISO standards (13485, 15189), CLIA accreditation, lab developed test, and clinical performance studies .Ability to synthesize and critically analyze data ... **Job Title:** GRA Device Associate **Location:** Cambridge, MA/ Morristown, NJ/ Washington DC...Our department bridges the gap between technical development, manufacturing operations , and global regulatory authorities to ensure compliance while… more
- Merck (Rahway, NJ)
- **Job Description** **Position Description:** ** Associate Director, DSCS Digital Implementation Project Manager** Within the Development Sciences and Clinical ... execution and management of DSCS Digital initiatives. Development Sciences and Clinical Supply (DSCS) enables Drug Substance, Drug Product, Analytical Development,… more
- Taiho Oncology (Princeton, NJ)
- …with team members. + Maintain training and oversight to clinical operations /pharmacovigilance vendors supporting pharmacovigilance activities, as needed. ... and evolving needs of patients. Advanced technology, a world-class clinical development organization, and state-of-the-art facilities: these and other resources… more
- Hackensack Meridian Health (Hackensack, NJ)
- …change. The ** Clinical Research Nurse** is responsible for coordinating and overseeing clinical operations of a clinical trial and participates in ... assessing, planning, implementing and evaluating Compliant Patient Care in clinical research studies . The Clinical Research Nurse carries out the research… more
- Hackensack Meridian Health (Hackensack, NJ)
- …The ** Clinical Research Coordinator** is responsible for coordinating and overseeing clinical operations of all assigned clinical trials and participates ... in assessing, planning, implementing and compliant study conduct according to all relevant local, federal, and...SOCRA-Certified Clinical Research Professional (CCRP) and/or Certified Clinical Research Associate (CCRA) and/or Certified … more
- ThermoFisher Scientific (Lawrenceville, NJ)
- …step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel ... frameworks for clinical research through our PPD clinical research...as per departmental guidelines * Prepare or contributes to study reports following the departmental policies and procedures. *… more
- GRAIL (Trenton, NJ)
- …and we are using the power of next-generation sequencing (NGS), population-scale clinical studies , and state-of-the-art computer science and data science to ... relevant documentation. The role collaborates cross-functionally with Quality, Lab Operations , and other stakeholders to support regulatory strategy development,… more