- Kailera Therapeutics, Inc. (Waltham, MA)
- …perspectives, and experiences to join our team. What You'll Do: The Associate Director, Clinical Data Management plays a key role within the Clinical ... with key stakeholders to implement a robust and transparent data strategy. They collaborate with CRO , and... delivery. This role reports to the Head of Clinical Data Management. Preferred location: Waltham, MA… more
- Medidata Solutions (New York, NY)
- …Inside Sales, Professional Services and Value Engineering. The Solution Sales Specialist, Clinical Data Studio, will shape and help execute Medidata's ... for data review, quality, and all other Clinical Data Studio(CDS) Capabilities within our platform....: Sales experience in the biopharma, life sciences, or CRO industry with a strong track record of consistently… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as well as other BDM functions, sets the vision, direction, and strategy for Clinical Data Management globally and ensures execution of the global data ... the function and cross-functionally to resolve issues pertaining to data management in clinical trials and submissions...thinking for outsourcing strategy. As a member of the CRO governance committee, provides strategic leadership in Data… more
- Lifelancer (Boston, MA)
- …monitoring from site qualification to site closure visits to assure integrity of clinical data with respect to accuracy, accountability and documentation through ... source documents, and medical records. Support the review/cleaning and reconciliation of all clinical data , including EDC, PROs, and 3rd party labs to support… more
- Abbott (Alameda, CA)
- …and audit Trial Master File to ensure inspection readiness. Perform review of clinical data listings for completeness and accuracy, and escalate issues to ... experience of the clinical trial process including study design and conduct; clinical data management systems; clinical trial management systems; data… more
- Formation Bio (New York, NY)
- …drivers. Facilitate effective communication and collaboration between internal teams, such as Clinical Development, Clinical Data Management, and Site ... and comply with regulations. Capabilities to include the operational aspects of clinical trials, including protocol development, site selection, data collection,… more
- Regeneron Pharmaceuticals, Inc. (Tarrytown, NY)
- …educational materials, trainings) In collaboration with Clinical Study Team (CST), completes clinical data reviews and activities prior to data cuts as ... The Study Medical Director, Clinical Sciences is responsible for facilitating assigned ovarian...(eg, interim analyses, DBLs, regulatory submissions, etc.) Communicates with CRO and study site personnel including investigators to answer/triage… more
- Green Line Talent Group (New Haven, CT)
- …to leadership with actionable solutions. Oversee collection, validation, and reporting of clinical trial data . Qualifications: Bachelors degree in life sciences, ... trial lead, with at least 2 years in a CRO oversight role. Strong knowledge of clinical ...therapeutic areas or global trial management. Proficiency with electronic data capture systems (EDC) and other relevant tools. Excellent… more
- Kodiak Sciences Inc (Palo Alto, CA)
- …Science, or a related field. 7+ years of experience in clinical data management within the biotech, pharmaceutical, or CRO industry. Experience managing ... integration and reporting. Contribute to the implementation and optimization of clinical data systems and tools (eg, EDC, data review platforms). Education… more
- Argenx (Boston, MA)
- …goals. The ideal candidate will have a strong understanding of both IT systems and clinical data . This position will report directly to the Trial Oversight and ... regulations, and organizational policies Skills and Competencies: Knowledge of clinical data and ICH-GCP, CDISC and other...Analyst or similar role 4+ years of experience in Clinical Development Experience at vendor side ( CRO … more
- Loyola University Chicago (Chicago, IL)
- …with good clinical practice guidelines. Collect, record and maintain complete data files using good clinical practice in accordance to HIPAA regulations. ... of study specimens and processing. *Collect and manage patient and laboratory data for clinical research projects. Manage research project databases, develop… more
- CryoLife (Kennesaw, GA)
- …analysis datasets and TLF delivery. Perform coding support for multiple functions, including clinical data management and clinical operations. Maintain and ... randomization, and statistical analysis plans to achieve study objectives. Collaborate with data management team and clinical operations team to align… more
- Recursion (New York, NY)
- …and involvement with invoice and contract review and approvals Experience working closely with data management and clinical teams to set up study systems and ... the integration of automated cell biology, high-dimensional and diverse data sets, and sophisticated analytics. We are seeking a...We are seeking a highly motivated and skilled Senior Clinical Project Manager within our Clinical Operations… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to determine risk factors with and for other technical departments (eg, Clinical , Medical, Safety, Data Management, Statistics). This position requires skills ... Collaboration and partnership with other functions and stakeholders in supporting clinical trial monitoring and execution through RBQM activities. Accountable for… more
- ProPharma Group (Western Springs, IL)
- …and marketing authorization submission documents) accurately and consistently present key data -driven clinical messages in accordance with program goals and ... field preferred. *At least 7 years medical writing experience in the biopharmaceutical/ CRO industry required or comparable experience within clinical or… more
- System One Holdings, LLC (Horsham, PA)
- …with Global Medical Affairs Lead (GMAL) and biostats, analyze and interpret clinical study data for abstract/posters, presentations, and manuscripts Collaborate ... process to facilitate timely publication development. *Maintain knowledge of clinical study data for assigned TA by...*Minimum of 5 years' experience writing publications in a CRO or pharmaceutical setting is required. System One, and… more
- Eisai, Inc (Nutley, NJ)
- …strategies.Experience in managing and directing related functions such as data management, CRO vendor management, procurement, and contracting.Excellent ... your profile, we want to hear from you. The Vice President/Head of Global Clinical Operations is a senior leadership role responsible for overseeing all aspects of … 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
- The University of Pennsylvania (Philadelphia, PA)
- …of health and wellness programs and resources, and much more. Posted Job Title Clinical Research Coordinator B Job Profile Title Clinical Research Coordinator B ... This position's primary function is to facilitate, promote, and ensure good clinical practice in the conduct of all research protocols in the Department/Center.… more
