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Line Management for members of the COPL organization. Responsible for performance management and optimization of members of the COPL team to achieve a consistently highly performing effective COPL tea...
Develops, generates and analyzes project progress and/or metric reports, reporting summary of findings and remediation activities, as required, to DM management, project team and Sponsor...
Analyze, report, and present metrics for assigned programs to development teams R&D, and Quality management; recommend any required actions and monitor implementation...
Leading cross-functional Site Selection Team to identify and determine interest and suitability of investigator's for participation in the assigned study. Developing Core Country Study Documents to in...
Accountable for the planning, implementation and execution of pivotal clinical trials, including study deliverables, milestones and data quality. Leads the Clinical Trial Team. Management oversight o...
Responsibility for delivery of business intelligence reporting and analytics solutions in at least four of the following business areas, depending on the Lead’s expertise and DFCI business need: Pharm...
Collaborate cross functionally with QA, Vendor Management, Research, Oncology Research, IT, CMC, and external vendors to develop and implement processes and standards...
Support the day-to-day operations of the Translational Pharmacology department by collaborating with Discovery/Pre-clinical Scientists, Clinical Assay Development, Biomarker Lead, Clinical Scientist/M...
Develops and maintains relationships with colleagues, vendors/CROs, investigators and site personnel to ensure successful completion of assigned clinical trials. Oversees study activities leading to a...
Lead development of risk based investigator site management program and oversee the conduct or management of relevant site, vendor, and/or process audits including, but not limited to: Clinical Study...
Driving innovation and the discovery of novel targets and therapeutic leads in kidney disease, and driving their progression to the clinic. Coordination of cross-functional, cross-site kidney diseas...
Serve as a lead statistician and manage statistical efforts for all the clinical pharmacology studies to be initiated across our clinical programs.
Participate in the preparation of registration clinical documentation (labeling, CTDs, overview summaries).
Lead the biostatistics activities in clinical development and medical affairs for assigned development portfolio. Take active role in supporting clinical trials from strategy, trials, approval and com...