Regional Clinical Study Senior Manager - Oncology/Hematology

Position Summary : Accountable for regional study delivery with appropriate inspection readiness quality, within agreed timelines and budgetActs as regional lead for multiple studies across an indication or across a program as requiredLeads the regional clinical operations team (including external partners working on a regional level) and acts as point of escalation for resolution of issues within the region for the assigned studyEnsures alignment of regional deliverables with overall study goalsContributes to the development of regional tools and leads the development of work instructions and SOPs as requiredEssential Functions of the job : Regional LeadershipLeads the regional clinical operations team effectively, ensures effective decision making and acts as point of escalation for resolution of issues within the region for the assigned studyLeads external vendors involved in study delivery on a regional levelCollaborates with key stakeholders in the region and provides regular updates on study progress in the region to senior management and Global Clinical Study Manager as requiredRepresents the regional study team at internal meetings and at the cross-functional Clinical Study Team (CST) meetingsLeads regional operations meetings with all regional study team membersDisplays therapeutic area knowledge and expertiseTimelines, Planning and ExecutionLeads planning and management of the assigned clinical study(ies) from feasibility through closeout activities for region, in line with global study timelinesGenerates, manages, and maintains high quality study start up and recruitment timelines for region and tracks progress towards theseEnsures that the clinical study is operationally feasible in the region, drives trial feasibility, country allocation and site selection process for assigned region in collaboration with feasibility managers, country heads, medical affairs and any other stakeholdersProvides regional input on global study plans as requiredEnsures timely availability of local adaptations of global study documents such as informed consent forms, in close collaboration with other key stake holders to ensure timely submission to regulatory authorities and ECs / IRBsAccountable for submissions of study in countries in assigned region in close collaboration with regional study start up team and regulatory affairsEnsures regional and country information in study systems and tools is entered and up to dateCollaborates closely with CRAs in the region to ensure proper study execution at the sites.

Reviews and signs-off monitoring reportsResponsible for working with regional and country teams to ensure that country and site level Trial Master File is created, maintained and QC’d on a regular basis as per the study TMF QC planProvides input to Global Clinical Supplies regarding drug inventories in region and reviews local drug labels for region.

Provides input on local regulatory approval and reimbursement status of comparator drugs used in study for countries in regionManages the trial data collection process for the region, drives data entry and query resolutionAs required, supports planning and execution of the Clinical Study Report in collaboration with Global Clinical Study Manager and Medical WritingQuality : Handles escalated issues or problems with the sites in region in close collaboration with stakeholders such as country headsMonitors study activities in region to ensure compliance with study protocol, SOPs, ICH / GCP and all other relevant regulationsEnsures inspection readiness for study in region at any point in time throughout the study life cycleInforms Global Clinical Study Manager of any issues arising on the study, evaluates impact and ensures solutions are implementedPrepares sites for quality assurance audits and inspections, drives responses to audit and inspection findings as appropriateCollaborates with CST members and othercolleagues to ensure cross-team, site learnings, and best practices are sharedLeads improvements and partners with CST members to enhance the efficiency and the quality of the work performed on assigned studiesLeads the development, optimization and review of work instructions and SOPs as requiredBudget and ResourcesWorks with the sourcing team to select and manage regional study vendorsManages regional study budgetsWorks closely with Clinical Business Operation on investigator fees, site payment issues and patient travel reimbursement activitiesIdentifies and manages regional team resource needs and establishes contingency plans for key resourcesMonitors regional resource utilization over study life cyle and liaises with functional managers as neededSupervisory Responsibilities : Provides performance feedback on team members as requiredMentors junior team members and might take on line management responsibilities as requiredComputer Skills : MS Office, Project Planning ApplicationsOther Qualifications : 6 or more years of progressive experience in clinical research within biotech, pharma or CRO industryProven experience in clinical research including relevant experience as team lead in clinical functionsExperience as CRA is preferredTravel : Travel might be required as per business needEducation Required : Bachelor’s Degree in a scientific or healthcare discipline required*, Higher Degree preferred*exceptions might be made for candidates with relevant clinical operations experienceAll qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.