Job Summary:

• Manage physician-initiated research projects with key opinion leaders worldwide
• Lead publications for clinical study data through coordination with investigator authors and project management of reviews and revisions for abstracts and manuscripts
• Presents scientific data by communicating accurate, succinct summaries of clinical results at industry gatherings, investigational meetings and regulatory agency meetings.
• Collaborate on the design of clinical studies in collaboration with internal stake holders including clinical project management and regulatory affairs, as well as external stake holders including scientific vendors and physician advisory committees.
• Generate study-related documents and/or contribute content and oversight of such documents, including, but not limited to, clinical study protocols, case report forms, clinical study reports, and clinical evaluation reports
• Develop and execute clinical evidence generation strategies in close collaboration with cross-functional teams
• Participate in and provide oversight of scientific report writing. 
• Presentation of methods, results and conclusions to a publishable standard
• Maintain and summarize relevant literature within the assigned therapeutic area
• Support marketing campaigns using clinical data
• Lead the development of statistical analysis plans with scientific vendors
• Contribute to the optimization of internal processes and workflows

Skills on Resume:

• Project Management (Hard Skills)
• Publication Leadership (Soft Skills)
• Data Presentation (Hard Skills)
• Study Design (Hard Skills)
• Document Oversight (Hard Skills)
• Evidence Strategy (Hard Skills)
• Report Writing (Hard Skills)
• Literature Review (Hard Skills)

Job Summary:

• Acquires and utilizes knowledge of clinical trial design to develop specific study synopses and protocols.
• Stays abreast of new developments in diabetes treatments and devices, and competitive products and experimental compounds. 
• Participate in competitive analysis in other disease states to support early phase pipeline candidates.
• Participates/leads protocol review discussions concerning scientific and procedural aspects of study design.
• Collaborates with key thought leaders to solicit input into protocols and other strategic development questions.
• Prepares study protocols, amendments, specific sections of study manuals and Investigator meeting notebooks, and other documents 
• Leads planning for Investigator meetings and presents compound and protocol overview at meetings.
• Contributes to the design and development of clinical data collection forms, Data Management Manuals and Data Analysis Plans.
• Addresses questions regarding scientific and related procedural issues from Investigators.
• Provides scientific and operational leadership and oversight of vendors and CROs.

Skills on Resume:

• Clinical Design (Hard Skills)
• Market Awareness (Soft Skills)
• Competitive Analysis (Hard Skills)
• Protocol Review (Soft Skills)
• Collaborative Development (Soft Skills)
• Document Preparation (Hard Skills)
• Meeting Leadership (Soft Skills)
• Data Management (Hard Skills)

Job Summary:

• Design innovative and feasible clinical trials in collaboration with clinical development team members.
• Regularly monitor, clean, analyze and review safety and efficacy data to identify and summarize findings and, as appropriate, may drive follow-up activities.
• Interface with discovery, safety sciences, statistics, PK/PD, regulatory, outcomes research, development operations, other members of the extended project team(s)
• Interact frequently with investigators, site staff, CROs, and site monitors to optimize study engagement, maintain enthusiasm, and support further enrollment for ongoing clinical studies.
• Maintain and analyze literature and competitive information for trial designs and results for assigned therapeutic area.
• Review and provide input on statistical analysis plan.
• Under medical supervision participate in tracking/analysis of any potential safety events within an individual clinical trial and across trials for assigned programs.
• Partner with Data Management for case report form (CRF) design, instructions for unique CRFs, and Data Quality Plan.
• Maintain current knowledge of the environment to ensure awareness of internal and external developments (scientific, clinical, competitive, and regulatory) that could impact the development plan
• Attending major scientific conferences, participating in competitive intelligence activities, and engaging in periodic literature review.

Skills on Resume:

• Trial Design (Hard Skills)
• Data Analysis (Hard Skills)
• Team Interface (Soft Skills)
• Stakeholder Engagement (Soft Skills)
• Literature Analysis (Hard Skills)
• Statistical Review (Hard Skills)
• Safety Monitoring (Hard Skills)
• Knowledge Maintenance (Soft Skills)

Job Summary:

• Ensure medical and clinical expertise is provided in the assessment and decisioning for complaint handling and reportability of commercial products.
• Provide clinical guidance to the Use Risk Related Assessment (URRA) team to establish the use-related risks are considered and mitigated to an acceptable level throughout the product development process to ensure safe and effective use.
• Provides guidance on ensuring patient safety is not compromised and risk is minimized when evaluating the relative impact of product failures and subsequent proposed product change
• Support the ongoing safety and risk assessment of patient safety during trial conduct and participates in product safety reviews including the appropriate tracking and follow-up of adverse events
• Plan, collaborate on and reviews scientific content of clinical documents such as protocols, informed consent documents, final study reports, and submissions (e.g., annual reports)
• Collaborate with clinical research staff in the design, conduct and reporting of clinical trials
• Participate in investigator identification and selection, in conjunction with clinical teams.
• Assist in planning process and participate in study start-up meetings and other activities to provide the appropriate training and information to investigators and site personnel.
• Serve as resource to clinical research staff, investigators and ethical review boards to address any questions or clarify issues arising during the conduct of study.
• Support the planning of investigator meeting, clinical and scientific advisory board meetings, and other meetings with health care professionals.

Skills on Resume:

• Complaint Handling (Hard Skills)
• Risk Assessment (Hard Skills)
• Safety Guidance (Hard Skills)
• Trial Safety Support (Hard Skills)
• Document Review (Hard Skills)
• Trial Collaboration (Soft Skills)
• Investigator Selection (Soft Skills)
• Meeting Support (Soft Skills)

Job Summary:

• Work collaboratively with R&D to plan and conduct laboratory experiments
• Coordinate and conduct the specimen-collection procedure with research participants, according to an IRB protocol
• Process, store, and ship biological samples according to specific protocol requirements
• Collect data as required by research protocols, including data organization and analysis
• Write research protocols and reports
• Periodic weekend work and long days may be required
• Support data analysis and the development of slide sets and publications (abstracts, posters, manuscripts).
• Evaluate the relevant medical literature, know the status and data from competitive diabetes technology devices and clinical research
• Keep updated with medical and other scientific developments relevant to diabetes.
• Work efficiently to facilitate information flow between team members, solve critical issues, and elevate specific concerns in order to uphold timelines while providing necessary attention to detail.

Skills on Resume:

• Experiment Planning (Hard Skills)
• Specimen Collection (Hard Skills)
• Sample Management (Hard Skills)
• Data Analysis (Hard Skills)
• Protocol Writing (Hard Skills)
• Flexible Scheduling (Soft Skills)
• Publication Support (Hard Skills)
• Literature Review (Hard Skills)

Job Summary:

• Lead development of Medical Monitor Plans, perform ongoing clinical data review and critical analysis of study data including partnering with clinical research physician in pharmacovigilance data reviews
• Provide support as needed for clinical and scientific issues that may arise during study execution. 
• Work closely with biostatisticians and programmers to plan analyses of clinical data and support data outputs for Board meetings, analyst events.
• Lead the development of clinical study protocol synopses and full protocols
• Lead the development of investigator brochures while contribute in the writing and review of clinical study reports (CSRs), data safety update reports (DSURs) and annual reports and regulatory briefing books. 
• Manage development of internal and external presentations/publications of clinical study data, participate in publication planning and contribute towards writing of departmental working processes (SOPs, templates).
• Assist clinical research physician in developing clinical development plans and contribute to the development of data collection tools, statistical analysis plans, case report forms.
• Perform literature searches and critically review and summarize the relevant scientific, drug development and medical literature to support document development, such as the investigator brochure, protocol design, clinical study report, competitive assessments.
• Provide scientific/medical supportive materials to in-house staff and external consultants in the indications being studied.

Skills on Resume:

• Medical Plan Development (Hard Skills)
• Clinical Support (Soft Skills)
• Data Analysis Planning (Hard Skills)
• Protocol Development (Hard Skills)
• Brochure Leadership (Hard Skills)
• Publication Management (Hard Skills)
• Tool Development (Hard Skills)
• Literature Review (Hard Skills)

Job Summary:

• Support the technical and scientific aspects of clinical trials as directed
• Support the internal and external collaborative partners by review of the literature, idea generation, framing the clinical research questions and associated hypotheses, clinical trial outcomes, and structural designs
• Conduct structured or systematic literature review search, including clinical literature, peer-reviewed publications, or reports
• Contribute to clinical trial protocol writing/review, method validation research, and feasibility assessments in collaboration with interdisciplinary teams of researchers, clinicians, and medical writers
• Support collaborative clinical partners by development of outlines, conduct revisions, perform proof-reading, and quality assurance tasks
• Perform medical writing and review of clinical study documents, including but not limited to consent forms, case report forms, and other clinical study documents (IND/CTA) in collaboration with cross-functional study teams
• Support the clinical data screenings, data analyses, and clinical study documentations
• Provide expert analysis, interpretation and summarizing of clinical study results, and appraise studies for study suitability and data contribution
• Work closely with interdisciplinary teams of internal and external researchers, clinicians, project managers, and regulatory entities to support proper execution of ZYUS clinical trials
• Collect and prepare required clinical documents to ensure compliance with International Product Registration mandates, global Health Authorities, and ZYUS ‘s internal standards and requirements
• Contribute to preparation of supporting clinical documents for regulatory submissions
• Support timely delivery of pre-clinical data review and assist with periodic review of study files for completeness
• Assist in development of evidence portfolio, including writing journal publications and summary articles, and technical clinical documents.

Skills on Resume:

• Clinical Trial Support (Hard Skills)
• Literature Review (Hard Skills)
• Protocol Writing (Hard Skills)
• Quality Assurance (Hard Skills)
• Medical Writing (Hard Skills)
• Data Analysis (Hard Skills)
• Regulatory Compliance (Hard Skills)
• Evidence Development (Hard Skills)