- Actalent (Parsippany Troy Hills, NJ)
- …vendor management including CRO oversight, other study service providers involved in a clinical trial . + Lead or support the cross-functional study execution ... + In conjunction with the legal team, facilitate the development of clinical trial agreements and other relevant documents. + Coordinate and lead study team… more
- Pfizer (New York, NY)
- The Late-Stage Clinical Scientist (non-MD, Senior Manager ) is responsible for scientific oversight, data integrity and quality of clinical trial (s) ... functional lines for the successful implementation and execution of the clinical trial (s) within the assigned program. + Responsible for scientific oversight,… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- The Senior Manager , Hematology, Clinical Scientist leads in the development, evaluation, planning and execution of clinical studies and ensures integrity ... on clinical studies and programs. As a Senior Manager in Hematology Clinical ...clinically relevant sections and review other scientific portions of clinical trial protocols and amendments + Assists… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- 1 of 2 Positions: As a Senior Manager in Clinical Sciences, Oncology, you will assist in the development, evaluation, planning and execution of clinical ... on clinical studies and programs. **As a Senior Manager in Oncology Clinical ...regulatory requirements and ICH/GCP guidelines. Proven track record in clinical trial process improvements. Considerable organizational awareness,… more
- Unilever (Englewood Cliffs, NJ)
- …Unilever's scale and network in the markets. Who You Are & What You'll Do Th e Clinical Development Senior Manager (CD M ) will play a critical role in ... Mapping for key scientific areas of interest including innovative clinical trial design + Generate e vidence...present information in a clear and concise manner to senior management + Networking and stakeholder management + Attention… more
- AbbVie (Florham Park, NJ)
- …concepts. + In-depth knowledge of CDASH and SDTM Standards In-depth understanding of clinical trial processes + Demonstrated ability to influence others without ... bringing people, process, and technology together to generate business value from clinical trials data. Our operational model is exemplified through execution and… more
- Regeneron Pharmaceuticals (Armonk, NY)
- The ** Senior Clinical Study Lead** (CSL) is expected to operate with high-degree of independence and is accountable for the global execution of assigned large ... study design, through execution, to study close out. The Senior CSL is accountable for the study timelines, study...maintenance of study systems including but not limited to Clinical Trial Management System (CTMS), Trial… more
- Regeneron Pharmaceuticals (Armonk, NY)
- The role of Senior Manager , Diagnostics Program Management & Operational Delivery, is expected to manage and deliver a portfolio of diagnostic projects (CDx, ... development and delivery of the diagnostic strategies. **As a Senior Manager , a typical day may include... clinical protocols, informed consent documents and other clinical trial deliverables and work with other… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …operational planning activities. This includes regular updates on new information that could impact clinical trial execution as well as ad hoc requests to input ... understanding of the drug development and commercialization process, with a focus on clinical development and trial execution + Experienced in understanding and… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- **SUMMARY:** We are seeking a Senior Manager of Global Patient Safety who will play a key scientific role in safety strategies for molecules in clinical ... and analysis to support appropriate safety interpretation and benefit-risk assessment. As a Senior Manager of Global Patient Safety a typical day might include… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- The Senior Manager of Global Patient Safety (GPS) will play a key scientific role in safety strategies for molecules in clinical development and ... and ICH guidelines, initiatives and regulations governing pharmacovigilance activities for both clinical trial and post-marketing environments + Ability to work… more
- Regeneron Pharmaceuticals (Armonk, NY)
- The Senior Manager , Pharmacy Support Lead (PSL) is responsible for driving activities related to Investigational Product used in the conduct of clinical ... Logistics Organization (CDSL), the Formulation Development Group (FDG), the Clinical Trial Management Team (CTM), and partner...patient compliance/adherence issues. **A typical day as a Sr Manager in this role looks like:** + Partners with… more
- Regeneron Pharmaceuticals (Armonk, NY)
- …Program Operations Leader and Clinical Study Lead(s) for one or more assigned clinical programs within Clinical Trial Management. The role is responsible ... and organization for GCP inspections with a focus on clinical trial management activities for assigned programs...etc.) + Provide periodic, executive summary updates to CTM Senior Leadership (eg Therapeutic Operations Leader, Heads CTM) on… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …+ If you are interacting with CROs in the management of ex-US/ex-EU CTAs towards clinical trial activations preferred + If you have a high attention to detail; ... The Sr. Manager , Regulatory Affairs will report to the Global...the development of novel therapeutics including quality, preclinical and clinical areas of drug development and the policies/procedures required… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …as a PV expert, managed quality and compliance issues related to post-marketing and clinical trial safety **To be considered,** we are looking for individuals ... compliance within global pharmacovigilance (PV) system. We expect the Sr. Manager to build strategic partnerships and direct risk-based quality management activities… more
- AbbVie (Florham Park, NJ)
- …environment. Understanding of relevant therapeutic area required. *Basic knowledge of clinical trial design, results and methodology, regulatory and compliance ... establishes current therapeutic expertise necessary to serve as scientific, medical, and clinical to field medical teams/affiliates, TA teams, brand teams and R&D… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …literature + Authors and/or reviews documents related to trials, such as clinical trial protocols, medical monitoring plans, SAPs, informed consents and ... process, regulatory requirements and ICH/GCP guidelines. Proven track in clinical trial process improvements. Organizational awareness, including significant… more
- Mount Sinai Health System (New York, NY)
- **Job Description** _This position will report directly to the Medicine Clinical Trials Office (MCTO) Research Manager to assist with management of the ... coordination in healthcare or basic research. + Experience in clinical research study or trial management preferred...updates on project status, potential issues, and progress to senior management. + Assist the MCTO in developing systems… more
- Kuehne+Nagel (New York, NY)
- …domestic airline routings, geography and time zones + Specific knowledge of Clinical trial Logistics to include: Temperature Controlled Shipping and Packaging, ... looking for a new Air Logistics Operational Key Account Manager to join our Air Logistics team. **Your Role**... Clinical Trial Courier Operations and client set… more
- Bristol Myers Squibb (Madison, NJ)
- …in their personal lives. Read more: careers.bms.com/working-with-us . Position Summary The Senior Manager of RWE Biostatistics is a member of cross-functional ... organizational skills + Ability to: - learn regulatory requirements & clinical trial design, data analysis and interpretation, - work successfully within… more