- Merus (Cambridge, MA)
- Clinical Trial Associate /Senior Clinical Trial Associate Department: Clinical Operations Employment Type: Full Time Location: Cambridge, MA Description ... The Clinical Trial Assistant (CTA) / Senior CTA plays a vital...standards. The CTA/Sr. CTA is responsible for maintaining essential trial documents, structuring filing systems, managing clinical systems, coordinating… more
- Dyne Therapeutics (Waltham, MA)
- …and follow us on X, LinkedIn and Facebook. Role Summary: The Clinical Trial Associate (CTA) provides Clinical Operations support in the initiation, execution ... for proactive, study-wide problem solving regarding study progress and trial issues during the study Track metrics related to...as internal meetings Collect and track documents for the trial master file (TMF), and perform TMF reviews to… more
- Merck & Co. (North Wales, PA)
- …field plus 9 years SAS programming experience in a clinical trial environment.MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering ... plus 7 or more years SAS programming experience in a clinical trial environment. Department Required Skills and Experience: Excellent interpersonal skills and… more
- Genmab (NJ)
- …like a fit? Then we would love to have you join us!The RoleThe Associate Director acts as a statistical expert supporting the clinical development of compounds as ... and/or indication lead for both early and late-stage programs, and/or as trial responsible statistician with responsibilities as described below. The Associate … more
- Merck & Co. (North Wales, PA)
- …for the operational planning, feasibility, execution and conduct of clinical trial (s).Serves as the Clinical Trial Team lead. Leads and ... subsidiary country teams, vendors, committees, etc.) in support of clinical trial objectives.Liaises with partners, vendors, and vendor management team . Review… more
- Merck & Co. (South San Francisco, CA)
- …West Point, PA / Rahway, NJ is seeking a curious and collaborative Associate Director to support our rapidly expanding cardiometabolic and ophthalmology pipelines. - ... As an Associate Director, you will represent QP2 on cr o...strategies ( translational PK/PD strategies, mechanistic model, POPPK/PD, clinical trial simulations, etc) for quantitative analyses, within and across… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …detection and characterization for ongoing studies and compound level pooled clinical trial data of project(s). Act as statistical expert consultant within company ... direction from group head and provide statistical scientific leadership for clinical trial safety data. Lead the statistical support for safety signal monitoring for… more
- Merck & Co. (San Francisco, CA)
- …of decision-making at our Company, this position offers an opportunity for the Associate Director to drive pipeline impact across therapy areas. - This Associate ... PK/PD models, exposure response (ER) models, model-based meta-analysis (MBMA), clinical trial simulations (CTS) and disease progression modeling into programs and… more
- Merck & Co. (San Francisco, CA)
- Job Description Position Description: Associate Director, DSCS Digital Implementation Project ManagerWithin the Development Sciences and Clinical Supply (DSCS) ... Under the broad guidance of the DSCS Digital Program Mgmt Lead, the Associate Director, DSCS Digital Project Manager, will be responsible for implementing improved… more
- Merck & Co. (Rahway, NJ)
- …chain across the full Company's Research & Development Division portfolio of clinical trial s .- GCS is accountable for the planning, sourcing, labeling, packaging ... and delivery of clinical supplies to clinical sites globally. The GCS Planning (Planning) organization is the key interface between clinical development teams and the operational/executional arms within the business.-- - - The Program Clinical Supplies Project… more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe Associate Vice President (AVP)/Section Head, Global Clinical Development, Pediatrics will focus on driving strategy, development, and life-cycle ... Clinical Investigations, Clinical Judgment, Clinical Reporting, Clinical Research, Clinical Trial Documentation, Clinical Trial Planning, Consultative Approach,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. Summary: Oversees typically a single non-pivotal trial (small size, standard complexity in design and geographic scope). Prepares ... guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to Clinical Operations. Represents… more
- Insmed Incorporated (Los Angeles, CA)
- …Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Associate Director Medical Science Liaison will develop and maintain professional ... Clinical Operations, and Medical Affairs Departments. This may include trial site identification, ongoing recruitment motivation, and issue/problem solving.Provide… more
- Merck & Co. (Rahway, NJ)
- …and increasing overall operational effectiveness.We are seeking a dynamic and experienced Associate Director of Outside Counsel and Vendor Management to join our ... Report Automation, Supplier Management, Team Leadership, Training and Development, Trial Preparation, Vendor Contract Negotiations, Vendor Management, Vendor Management… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …analyses and collection, missing data, demographic/representativeness of samples from clinical trial and screen failures.Clinical trial protocol development and ... reviews (clinical trial protocols and medical device protocols)ICF reviews to ensure adequate disclosure for collection, retention, testing and retesting of samplesProject Team Participation: Provide device-specific regulatory insight/guidance during CDx… more
- Formation Bio (New York, NY)
- …to patients faster and more efficiently.About the PositionWe are seeking an Associate Director, Program Management to drive the execution of critical drug ... execution, ensuring the team stays at the forefront of innovation in clinical trial operations. About You You're excited about the intersection of AI and program… more
- Eisai, Inc (Nutley, NJ)
- …difference. If this is your profile, we want to hear from you. The Associate Director (AD), Global Medical Affairs Training and Education is responsible for the ... training (eg medical insights workshops, presentation skills, understanding clinical trial design, statistics, etc.) to supplement MSL development.Collaborate with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …technical teams in preparation of submission documents to include clinical trial applications/amendments (eg, IND, IMPD, IB) and marketing applications/supplements & ... variations (eg, NDA, BLA, MAA). This position authors regulatory documents where necessary with supervision. This position conducts regulatory risk assessment and recommends developmental options with supervision, and this position acts as the company liaison… more
- Merck & Co. (North Wales, PA)
- …and vaccines for the benefit of patients and global human health.The Associate Vice President (AVP), Late Development Statistics, BARDS, is responsible and ... skills, expertise in leading large teams in the development of novel clinical trial designs and analysis methods in oncology, experience in directing multiple teams… more
- Aequor (Thousand Oaks, CA)
- …and implementation of both new technologies, new processes.Job Description: Clinical Trial Delivery Operating Model: Develop Data Management playbook to encompass ... (clinical operations, site management, biostatistics, stats programming, TA) to optimize trial delivery. Deep understanding of Risk Based approaches and its impact… more
