Clinical Research

• Oversees all aspects of study coordination and study conduct for multisite investigator-initiated studies.
• Serves as the primary contact for external subsites on all project-related operational matters.
• Collaborates with Principal Investigator (PI) on project design and development of study protocol and informed consent form (ICF).
• Completes all regulatory submissions including Protocol Review and Monitoring Committee (PRMC), Institutional Review Board (IRB), Data Safety Monitoring Committee (DSMC).
• Coordinates with Clinical Research Subsite Navigators.
• Creates the electronic data capture (EDC) system in collaboration with developers.
• Generates subsite data completion metrics for distribution to subsite PIs and study teams.
• Develops and implements a project-specific monitoring plan.
• Performs remote monitoring visits to review data timeliness and accuracy.
• Plans subsite Site Initiation Visits (SIV).
• Prepares and presents study metrics, progress, and long-term goals at Steering Committee meetings.

Clinical Research Project Associate

• Provide strategic HCC leadership, oversight and execution of the G lobal Health Care Compliance program for R& D, Clinical Research, Medical Affairs, and related activities.
• Act as a compliance partner and trusted advisor to G lobal R&D, Clinical Research and Medical Affairs teams, providing timely , practical guidance on clinical trials, investigator and site interactions, advisory boards, and scientific exchange.
• Assist in identifying , assessing, and mitigating compliance risks associated with clinical research activities and medical engagement models.
• Support compliance risk assessments, issue management, and monitoring activities related to R&D, Clinical Research and Medical Affairs.
• Collaborate with Legal, Privacy, Quality, Finance, and other assurance functions to deliver coordinated compliance support and risk mitigation.
• Contribute to the development, implementation, and maintenance of policies, procedures, and training materials related to R&D, Clinical Research and Medical Affairs compliance.
• Support responses to internal inquiries, audits, monitoring activities, and regulatory requests related to clinical and medical compliance topics.

Clinical Research Manager, Medical Affairs

• Perform statistical analyses to support clinical and methodological research studies
• Collaborate with multidisciplinary teams across MSK and external international partners
• Apply and develop machine learning approaches, particularly for pathology image analysis
• Write and maintain clean, reproducible code for complex datasets
• Contribute to study design, data interpretation, and the preparation of manuscripts and presentations
• Support ongoing large-scale research initiatives and ensure high-quality data outputs
• Participate in continuous learning and development in biostatistics and analytical methods

Assistant Research Biostatistician

• Full accountability for country-level study delivery and performance
• Serve as the client’s voice within Civia, ensuring their priorities, timelines, and standards are understood and met across all functions
• Maintain disciplined oversight of start-up, recruitment, regulatory progress, data quality, and site performance
• Drive immediate cross-functional action when performance deviates from plan
• Lead structured governance routines with clarity, transparency, and solution orientation
• Ensure ongoing audit and inspection readiness across all study activities

Clinical Trial Manager

• Lead in the development, evaluation, planning and execution of clinical studies
• Ensures scientific integrity and interpretation of study data of a clinical development program
• Collaborates closely with Medical Director (MD) to provide scientific expertise
• Develops/maintains proficient understanding of therapeutic disease area(s) and drug candidate
• Applies basic scientific expertise to support initiation and execution of clinical research and development studies for early and/or late-stage assets
• Contributes to program team meetings, scientific advisory boards, study steering committees and data/safety monitoring meetings
• Assists with development of the Expanded Synopsis and may author clinically relevant sections

Manager, Clinical Scientist, Hematology

• Support Omada’s research program by coordinating day‑to‑day study operations for assigned protocols, including tracking enrollment targets, participant flow, and key milestones.
• Contact study participants to facilitate timely, complete and accurate participation in study.
• Respond to questions and requests from research participants, escalating complex or clinical issues to the appropriate team member per protocol.
• Coordinate transfer of data between company and collaborating institutions, following data‑handling and privacy procedures.
• Maintain accurate study documentation and trackers (e.g., enrollment logs, contact logs, data transfer records) so the team has a current view of study status.
• Monitor day‑to‑day study progress, proactively flag risks to timelines or data quality, and recommend practical options to keep the work on track.
• Participate in regular study team meetings and status reviews, providing clear updates on your assigned workstreams and dependencies.

Clinical Research Coordinator

• Conduct and coordinate all aspects of clinical trial activities at the site.
• Perform phlebotomy on patients, following proper clinical and safety protocols.
• Recruit, screen, and enroll study participants according to inclusion/exclusion criteria.
• Schedule and conduct study visits, ensuring adherence to protocol requirements.
• Accurately collect, process, and ship biological samples per study-specific guidelines.
• Complete and maintain study documentation, including source documents, regulatory binders, and informed consent forms.
• Perform timely and accurate data entry into electronic data capture systems (EDC).
• Communicate effectively with sponsors, monitors, and other research team members.
• Ensure compliance with GCP, ICH, FDA, and IRB regulations.
• Assist in monitoring visits and audit preparation as needed.

• Lead day-to-day management of clinical studies to ensure delivery against timelines, budget, and quality expectations
• Drive study milestones and proactively identify and mitigate risks
• Oversee CROs, laboratories, and vendors to ensure performance aligns with scope, timelines, and budget
• Manage vendor relationships, including scope changes, issue resolution, and ongoing performance oversight
• Partner with internal stakeholders across Clinical, Regulatory, Data Management, and other functions
• Serve as a central operational lead to ensure alignment and efficient study execution
• Contribute to study planning, including timelines, resource plans, budgets, and risk management strategies
• Provide operational input into protocol development, feasibility, and study design
• Act as the primary sponsor contact for study sites
• Oversee site startup and ongoing site management activities
• Ensure proper sample handling, data flow, and protocol adherence
• Ensure compliance with ICH/GCP, FDA regulations, and company SOPs
• Maintain inspection readiness and support audits and regulatory inspections
• Ensure completeness and integrity of the Trial Master File (TMF)
• Author and review study plans, operational documents, and training materials
• Communicate study status, risks, and mitigation plans to stakeholders
• Contribute to process improvements and operational excellence initiatives
• (Sr. CTM) Lead cross-study or departmental initiatives

Clinical Trial Manager – Senior

• Collect, abstract, and enter data for research projects, databases, and/or protocols (clinical trials)
• Ensure data quality and integrity throughout the life of the study
• Collaborate with research and care teams across MSK regarding data input
• Generate data reports and deliver them to all vital parties on the progress of the research project, database, or protocol
• Design and/or improve databases, data forms, and tools (e.g. patient/human subject calendars, schedules, tracking logs) to facilitate patient consent and specimen collection as needed for assigned research projects
• Ensure all appropriate Institutional, State, and Federal regulations throughout the study are followed
• Coordinate clinical research protocols and serve as the main point of contact, if applicable

Clinical Research Coordinator – Global Cancer Research & Training Program

• Manage research projects and partnerships, including both scientific guidance and execution of the research deliverables
• Lead research projects from pre-sale alignment through study execution
• Collaborate with Research and Medical team members on internal projects to expand and/or validate research offerings
• Support research deliverable execution in a subset of research projects
• Contribute to internal and external meetings related to research
• Draft project collateral for studies for which you will be responsible
• Lead the development of project collateral, research protocols, abstracts, posters and manuscripts
• Effectively partner with Research Data Scientists to execute on active research projects
• Run internal and external meetings related to research
• Support the Commercial team in sales engagements
• Collaborate cross-functionally to address data, quality and research questions/needs

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