- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to provide strategic thinking for outsourcing strategy. As a member of the CRO governance committee, provides strategic leadership in Data Management related ... immune disorders. Job Summary: Position sets the vision, direction, and strategy for Data Management globally and ensures execution of the data management… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …case review, documentation reviews in collaboration with the ICSR management and CRO /Vendor oversight groups for case processing activities and reports to the ... matter expert in ICSR standards, decision making and trouble shooting. Identifies CRO /vendor training as needed. Reviews overall processes and identifies areas of… more
- NAES (Niles, MI)
- …and the transition to more sustainable energy. Opportunity Summary The Relief Operator / Control Room Operator ( CRO ) plays a critical role in ... plant equipment both in the field and from the control room . This position supports daily operations,...multiple operational functions. Your scope of responsibility as Relief Operator / CRO will include the following… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …on Project Teams.Responsibilities: Study Strategy: Provides the strategic direction to Biostatistics Data Management & Data Ops for EDC, edit checks, ... data quality listings, SAP, Data Management plan; Reviews patient population and protocol compliance...KOLs, Ad Boards for protocol development; Provides input on CRO / ARO Statement of Work and Budget; Establishes… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …different disciplines and cultures. Must have technical knowledge on integrated data review and derivation/interpretation of metrics that can dynamically interface ... factors with and for other technical departments (eg, Clinical, Medical, Safety, Data Management, Statistics). This position requires skills in working in a… more
- Eisai, Inc (Nutley, NJ)
- …strategies.Experience in managing and directing related functions such as data management, CRO vendor management, procurement, and contracting.Excellent ... communication and interpersonal skills.#LI-CCEisai Salary Transparency Language:The base salary range for the Vice President, Global Clinical Operations is from :347,400-456,000Under current guidelines, this position is eligible to participate in : Eisai Inc.… more
- MMS Holdings Inc. (Canton, MI)
- …where you'll be part of a supportive, innovative team? MMS is a award-winning, data -focused clinical research organization ( CRO ). We pride ourselves on being a ... medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four… more
- Recursion (New York, NY)
- …in Clinical Study Meetings, ensuring proactive alignment of expectations between the CRO and Recursion regarding all data -related deliverables. Work with ... through the integration of automated cell biology, high-dimensional and diverse data sets, and sophisticated analytics. We are seeking an Associate Director,… more
- Lifelancer (Boston, MA)
- …and oversee the planning and management of the operational aspects, including CRO and vendor oversight, to achieve project milestones and clinical study timelines ... Ownership of all operational aspects of designated clinical trial, including CRO and vendor management. Support and manage various study activities, including… more
- Tempus (Chicago, IL)
- …about the right treatments for the right patients, at the right time. The Data Operations Manager plays a critical role in enabling high-quality data delivery ... This role is responsible for scoping new assay and data product launches, documenting client requests via data...and storage platforms (AWS, GCP etc) Advanced Excel ability CRO experience and knowledge of the oncology space Knowledge… more
- Columbia University (Fort Lee, NJ)
- …to find solutions that can benefit multiple specialties. Extracts, collates, and refines data from multiple sources to manipulate into one reporting set using excel, ... stakeholders. Participates in developingbest practices for relevant changes. Present data , analysis, and recommendations for solutions in meetings with departmental… more
- REGENXBIO (Rockville, MD)
- …CTT team meetings and other internal meetings as required Responsible for management of data management and clinical operations teams in review of clinical data ; ... for the selection and oversight a study specific and GCP training of CRO study staff, clinical monitors, investigational sites and vendors Manages CRO /vendor… more
- Olema Oncology (Boston, MA)
- …research / development and manufacturing organizations) to ensure appropriate quality control checks are proceduralized and implemented for all labeling activities. ... as a strategic cross-functional partner working closely with the CMO/ CRO labeling specialists, cross-functional project teams including Quality, Regulatory, Clinical… more
- PTC Therapeutics (Warren, NJ)
- …Leads the statistical programming project team (including Clinical Research Organization ( CRO ) oversight as necessary) in support of clinical development programs in ... the assigned therapeutic areas. Ensures timely statistical analyses of clinical data per protocols and Statistical Analysis Plans; develops statistical programs and… more
- Aditum Bio (Cambridge, MA)
- …of concept. The firm focuses on the translational phase of medicine to generate data that can support full clinical development, and eventual market launch, to reach ... strategy, budget and milestone development, vendor identification. Contribute to CRO and site engagement, evaluation, and contracting processes. Lead internal… more
- Eli Lilly and Company (Boston, MA)
- …including study design, safety management plans, protocol writing, regulatory documents, CRO interactions, study start up, investigator interactions, data ... doses, dose ranges and in interpreting emerging human PK/PD data to inform dose escalation and dose regimen selection...relevant medical and scientific literature; know the status and data from relevant competitive assets and keep updated with… more
- IQVIA, Inc. (Durham, NC)
- Senior Data Analyst - HEOR (Oncology) Job Overview IQVIA is hiring to expand our dedicated Real World Evidence (RWE) FSP team, working fully within the environment ... of a prominent Pharma company. This senior data analyst role sits within our Real World Solutions team and will be responsible for leading development of datasets… more
- Revolution Medicines (Redwood City, CA)
- …for Clinical Operations. Prepare month-end clinical trial accruals, including review of CRO reports, patient costs, and site payments. Prepare monthly and quarterly ... and strong attention to detail. Experience in reviewing clinical contracts (ie CRO contracts, Site contracts, protocols, etc.). Strong work ethic and ability to… more
- GenScript/ProBio (Piscataway, NJ)
- …team environment. Good communication skills and the ability to clearly document and present data . Experience working in a CRO or CDMO setting is an advantage. ... its leading gene synthesis technology, including operation as a Life Science CRO , enzyme and synthetic biology products, biologics development and manufacturing, and… more
- Genmab A/S (Princeton, NJ)
- …compliance across all activities. Site Selection and Management Collaborate with the CRO and/or internal functions to oversee site selection based on feasibility ... timelines Participate in the selection and approval of key CRO personnel, such as Clinical Leads and trial-specific CRAs,...Clinical Trial Management Systems and Tools Drive the Operational Data Base review for the trial Engage in Risk… more
