Major Tasks and Responsibilities of Position
Manages and is responsible for all activities related to complex phase I and extended phase I/IIa clinical trials from the approved study concept to the clinical study report.
Develops and Leads a Study team, manages all Study Team activities as defined per SOPs/OIs and ensures the organization of regular Study Team meetings. Develops and manages budget, timelines and quality of the study and its deliverables. Responsible for forecasting and tracking of study costs. Ensuring all relevant IT-systems are updated with current and accurate information (e.g. IMPACT) Responsible for training and oversight of CROs to ensure compliance with timelines and budget.
Together with OPL and ECL/CPL and with guidance of the Head Study Management China is responsible for selection and oversight of External Suppliers (e.g. site management and monitoring CROs, Central Labs, central ECG reading center, etc.), developing the total external study budget and accountable for providing monthly and yearly estimates, tracking study budget, initiating payments, providing monthly information to controlling, OPL, ECL/CPL, identifying budget/estimate issues and proactively developing a plan for resolving study finance issues.
Writes protocols and amendments in collaboration with study team members. Responsible for study specific feasibility and site selection to meet study enrollment and timelines. Responsible for timely delivery of all start up activities e.g. CRO selection, CRF development, drug forecasting, study manuals, monitoring plan, data management plan, definition of end points, selection of safety and efficacy assessments, recruitment planning and oversight.
Tracks and compiles patient enrollment, data cleaning progress and overall study progress and ensures study timelines are met. Develops appropriate study related training for monitors and site personnel according to GCP and company standard. Ensures accurate data collection, protocol adherence, patient safety, PK, PD, biopsy sample integrity and GCP compliance. Escalates severe deviations to a key parameter (i.e. recruitment, timelines, patient safety, protocol compliance, data collection/cleaning, budget) after discussing and in alignment with the Study Team to OPL and /or ECL/CPL and functional manager.
Point of contact for managing/answering questions related to trial procedures and patients’ eligibility
Ensures clinical trial registry and results posting according to global requirements and guidelines, manages the study insurance according to required timelines
Ensures set-up, maintenance and Quality Control of the study Trial Master File (TMF)
Conducts lesson learned at any point in time when requested by management or any Study Team member and mandatory at study closure.
