Senior Clinical Trial Manager

Das ist der Job

Presents (as needed) trial related topics at CTT, Investigators and Monitors meetings.

Darum lohnt es sich

This position will lead the local medical team, ensure alignment and execution of local/regional medical strategy, collaborate with cross-functional teams and influence key healthcare stakeholders to drive meaningful impact for patients and the business.

Organizes, monitors and tracks the testing of data entry screens (eCRF layout), data cleaning / review tools, and their implementation in the production environment Organizes, monitors and tracks data cleaning, data review, query management, and database lock; makes sure processes are driven in collaboration with key Clinical Development (CD) stakeholders Generates trial metrics and status reports Represents Data Management (Biometry) at Clinical Trial Team (CTT) meetings.

Handles External Vendors, including participation to vendor selection (BID defense attendance, RFP and budget reviews), and vendor oversight FSP (if applicable) monthly invoices check FSP team members onboarding and trial related training Forecasts trial team resource requirements.

About Your Skills & Experience For this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills, and experiences: A master’s degree in life sciences, mathematics, statistics, informatics or related disciplines is required 5+ years of experience in the Pharmaceutical or Biotech industry within Clinical Research and/or Clinical Data Management with a strong level of functional expertise in Data Management are required Good knowledge of international clinical research regulations and requirements (e.g., International Conference on Harmonization – Good Clinical Practice (ICH/GCP)) Experience in clinical trial databases and applications, clinical data flow, data review, and (e)Case Report Form (CRF) design Ability to lead and coordinate the activity of DATA MANAGER(S) and of TRIAL DATA MANAGER(S) allocated to his/her trial Good organizational and presentation skills #J-18808-Ljbffr Ensures Data Management activities related to assigned trial adhere to clients standards, applicable regulations Meets trial timelines in terms of DM deliverables Ensures data handling consistency within allocated trial(s) Lead DM activities for assigned trial Provides DM input to the development of the trial protocol Coordinates the development of the (e)CRF in line with clients standards Writes all trial Data Management documents covering specifications for external data transfer, data cleanings and review tools that will be further provided to DM PROGRAMMERS for development for the allocated trial(s) Prepares and archives Data Management trial documentation.

Manages and is accountable for Data Management activities in studies where DM outsourced (insourcing/outsourcing partners’ management). Participates in development and review of policies, Standard Operating Procedures (SOPs), and associated documents for Data Management.

Represents Data Management in cross-functional working groups related to the system /process. Sets annual goals and appraises performance of direct reports Ensures DATA MANAGER(S) and TRIAL DATA MANAGER(S) assigned to trial has/have required training.

Ensures annotated CRF is created, validated, and provided as per agreed timelines Performs and/or coordinates Quality Control (QC): Periodic operational checks to verify that clinical data are handled according to protocol, applicable Quality System (QS) documents and GCP. Acts as Data Manager for studies when no Data Manager is assigned.