Job Summary:

• Take responsibility for clinical study protocol development and medical monitoring activities in phase I/II & potentially phase III clinical studies.
• Develop or support preparation of study related documents (e.g. study protocol, IB, ICF, SAP) and publications.
• Provide medical support to the study team, including products and protocols training
• Answering questions from study team and clinical sites, reviewing protocol deviation log, etc.
• Fulfill study tasks and other assigned tasks by cross-functionally interacting with other departments of the company, e.g. translational pharmacology, clinical operations, drug safety and regulatory.
• Review clinical study data for safety reviews and clinical trial data analyses.
• Interact and collaborate with external service providers and expert consultants.
• Actively contribute to reach the companies goals by supporting, discussing and executing a clear and integrated clinical development strategy.

Skills on Resume:

• Protocol Development (Hard Skills)
• Medical Monitoring (Hard Skills)
• Document Management (Hard Skills)
• Team Training (Soft Skills)
• Cross-functional Interaction (Soft Skills)
• Data Safety Review (Hard Skills)
• External Collaboration (Soft Skills)
• Strategic Development (Soft Skills)

Job Summary:

• Act as medical point of contact during the course of the clinical studies
• Take responsibility for the medical aspects of clinical trials within the clinicial study team
• Ensure patient safety, quality of medical data, and the best possible drug development
• Support organization with expert knowledge and insight into the clinical studies as well as act as point of reference for the country medical contact persons
• Review the patient medical data during the clinical study to identify possible safety or data quality issues
• Support the coding team for the medical history, concomitant medications and adverse event coding
• Be responsible for the content of medical sections of protocols/amendments
• Participate in the selection of the Clinical Research Organizations (CRO)
• Train the study teams, monitors, site staff and CRO's on medical aspects of the clinical studies, indications and compound

Skills on Resume:

• Medical Liaison (Soft Skills)
• Clinical Trial Oversight (Hard Skills)
• Patient Safety Assurance (Hard Skills)
• Clinical Expertise (Soft Skills)
• Data Quality Review (Hard Skills)
• Coding Support (Hard Skills)
• Protocol Development (Hard Skills)
• CRO Selection (Hard Skills)

Job Summary:

• Participates as a standing or ad hoc member in sub-teams (e.g., Study Management Teams) relevant to assigned molecule(s)/indication(s) and supports the MM and SMT to enable effective and efficient CD plan execution
• Supports the Clinical Sub Team (CST) lead and overall team with training new SMT members
• Clinical Development Plan Implementation
• Provides clinical support across all relevant studies and programs:
• Assistant MM for clinical science related working
• Participates in ongoing SMT/CST and relevant sub-team meetings
• Designs and develops clinical studies for review and discussion with other CST members
• Participates in investigator and other external presentations, meetings and other communications
• May support clinical operations, clinical research organizations (CROs), etc. by assisting MM for questions, other communications, and interactions
• Conducts ongoing data review of medical/safety data for assigned studies
• Supports, as needed, completion of interim study reporting and DBL for final reporting
• Works with other SMT/CST members, regulatory and other internal partners/stakeholders in the completion and submission of regulatory filings and other regulatory documentation.
• Develops presentations for other SMT/CST members
• Completes other special projects, as and when assigned, or otherwise requested
• Consistently complies with all governing laws, regulations, Roche Standard Operating Procedures (SOPs) and other guidelines

Skills on Resume:

• Team Collaboration (Soft Skills)
• Training Development (Soft Skills)
• Plan Implementation (Hard Skills)
• Clinical Study Design (Hard Skills)
• Data Review (Hard Skills)
• Regulatory Support (Hard Skills)
• Presentation Development (Soft Skills)
• Compliance Adherence (Hard Skills)

Job Summary:

• Responsible for supervising the trial site and delegating all tasks associated with it
• Oversee all team members and ensure they perform their duties according to set protocols
• Ensure that access to all tools compatible with what is required in the study protocol is accessible to everyone
• Follow specific regulations whilst conducting the studies
• Ensure all medical records/study documentation is accurate
• Conduct clinical studies in accordance to Good Clinical Practice.
• Maintain communication with the relevant ERB (e.g. obtaining approval, safety mailing submission, etc.).
• Obtains informed consent from subjects.
• Performs screening of potential study subjects.
• Medical supervision of study implementation in line with the protocol.
• Medical supervision of safety of subjects on study and whilst resident in the Clinical Research Unit.
• Manages/reports adverse events, intercurrent illnesses.
• Leads in responding to medical emergencies.

Skills on Resume:

• Trial Site Supervision (Hard Skills)
• Team Oversight (Soft Skills)
• Tool Accessibility Management (Hard Skills)
• Regulatory Compliance (Hard Skills)
• Documentation Accuracy (Hard Skills)
• Clinical Practice Adherence (Hard Skills)
• ERB Communication (Soft Skills)
• Medical Supervision (Hard Skills)