- Merck & Co. (North Wales, PA)
- …execution of clinical protocol(s). This may include:Serving as the lead clinical scientist on a clinical trial team.Leading medical monitoring team ... and prioritization skillsStrong analytical skills with the ability to interpret clinical trial data and synthesize conclusionsInteract with key stakeholders… more
- Merck & Co. (North Wales, PA)
- …of one or more clinical trials in the lung cancer program. Assists the Lead Clinical Scientist and study team with the scientific conduct of clinical ... management and prioritization skills.Analytical skills with the ability to interpret clinical trial data and synthesize conclusions.Interact with key… more
- Merck & Co. (Rahway, NJ)
- …who provide resources and services that are critical to the success of Global Clinical Trial Operations (GCTO) and Global Clinical Development (GCD) ... have direct management responsibilityRequired Experience and Skills:10+ years of clinical trial experience.Proven partner/supplier management experience.Must demonstrate… more
- Merck & Co. (North Wales, PA)
- … Clinical Safety StatisticsInteract with Safety Physicians, Safety Scientists, Clinical Trial Physicians , Regulatory, Early/Late Development Statistics, ... project management skills. --Good understanding of worldwide regulatory requirements and clinical trial expertise .Strong oral and written communication skills.… more
- Merck & Co. (North Wales, PA)
- …including those new to the organization therefore requiring someone who has built and lead clinical development plans from the ground up. They will also be ... directors responsible for clinical programs.Supervises development of clinical documents including development plans, protocols, trial related documents,… more
- Merck & Co. (North Wales, PA)
- …software eg SAS and/or R.Thorough understanding of worldwide regulatory requirements and broad clinical trial expertise from phase I to V.-Strong oral and ... and statistical analysis methods fundamental to effective pharmaceutical R&D. The Clinical Safety Statistics (CSS) group within BARDS supports proactive assessment,… more
- Merck & Co. (Rahway, NJ)
- …validation and transfer of release, characterization, and stability assays for testing of clinical trial material and in support of product and process ... join our Large Molecule Analytical Validation team to serve as an Analytical Program- Lead . The lead must take charge in overseeing and guiding analytical… more
- Merck & Co. (North Wales, PA)
- …the Specialist will be responsible for : - Authoring accurate , clear and health literate clinical trial PLS for posting on EU Clinical Trial Information ... quality - Building expertise in the regulations associated with clinical trial PLS and adapting to the...by site or organization, with Friday designated as a remote -working day, unless business critical tasks require an on-site… more
- Merck & Co. (North Wales, PA)
- …in meetings with investigators and regulatory agencies in discussions about clinical trial issues and submission strategies.Ensures the statistical designs ... Involved in research activities for innovative statistical methods and applications in clinical trial development. Education and Minimum Requirement: PhD or… more
- Merck & Co. (North Wales, PA)
- …in research activities for innovative statistical methods and applications in clinical trial development.-Mentors and guides junior staff in functional ... processing software eg SAS and/or R.-Good understanding of worldwide regulatory requirements and clinical trial expertise from phase II to V.-Strong oral and… more
- Eisai, Inc (Nutley, NJ)
- …a scientific or clinical setting.Strong broad-based scientific and pharmaceutical knowledge. Clinical trial development and drug launch experience is strongly ... and its hhc mission; b) provide key scientific and clinical information about Eisai's products; serve as a conduit...congresses in accordance with MSL plan. Be prepared to lead congress coverage efforts, including coordination of all MSL… more
- Eisai, Inc (Nutley, NJ)
- …includes overseeing the daily global eTMF system related activities relating to clinical study Trial Master Files (TMF), ensuring regulatory inspection-readiness ... to hear from you. The Sr. Manager is to lead collaboration efforts with R&D IT to implement and...position may be office-based (hybrid) in Nutley, NJ or remote based. Will include but will not be limited… more
- AbbVie (Chicago, IL)
- …Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Manager of the Clinical Trial Strategy and Submission delivers clinical development ... achieved in accordance with global regulatory strategies and compliance with evolving global clinical trial legislation (including the EU Clinical Trial… more
- Astellas Pharma (South San Francisco, CA)
- …regulatory commitment trials (interventional and non-interventional). This position is accountable to the Clinical Trial Lead and Operations Lead for ... on Astellas, please visit our website at www.astellas.com . Remote work from certain states may be permitted in... trial progression to Clinical Operations Lead , Clinical Trial Lead… more
- Merck (Rahway, NJ)
- …+ Defines trial -level requirements for quality data collection and validation at the trial level. + Read and interpret the clinical protocol from a ... more senior staff, may serve as the data management lead or perform a support role for filing programs....clinical data management perspective. + Provide clinical data management input into trial design,… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …knowledge. **Job Description** **_OBJECTIVES/PURPOSE_** As the Global Platform Manager for Clinical Trial Recruitment working in the Enterprise Medical Digital ... primary liaison across R&D, Medical Affairs, and Commercial in support of Takeda's Clinical Trial Recruitment Technologies. In this role, you will drive Takeda's… more
- Bristol Myers Squibb (Princeton, NJ)
- …personal lives. Read more: careers.bms.com/working-with-us . **Functional Area Description** The Clinical Trial Physician sits within Clinical Development, ... Development Expertise & Strategy + In collaboration with the Clinical Development Program Lead , designs and develops...key Health Authority interactions and advisory board meetings as Clinical Trial Physician + Authors/drafts clinical… more
- Bristol Myers Squibb (Cambridge, MA)
- …of expertise in key Health Authority interactions and advisory board meetings as Senior Clinical Trial Physician + Authors/drafts clinical content for CSRs, ... Development Team (CDT) + Leads medical data review of trial data, including eligibility review + Holds responsibility for...Development Expertise & Strategy + In collaboration with the Clinical Development Lead , designs and develops … more
- Merck (Columbus, OH)
- …if we are the right company for your long-term goals. Our company's Global Clinical Trial Operations (GCTO) team is currently recruiting for summer interns. GCTO ... that last up to 12 weeks and will include one or more projects. These opportunities in Clinical Operations can provide you with great development and a chance to see… more
- AbbVie (Florham Park, NJ)
- …and Statistical Sciences at any meetings with FDA and regulatory agencies regarding assigned clinical trials + Lead clinical study team in the development ... of key clinical trial systems, study conduct and study close-out as related...trial from initiation through to completion in a lead role is preferred + Demonstrated performance as a… more
