Regional Clinical Study Manager

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

Position Summary:

Accountable for regional study delivery with appropriate inspection readiness quality, within agreed timelines and budget

Acts as regional lead for multiple studies across an indication or across a program as required

Leads 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 study

Ensures alignment of regional deliverables with overall study goals

Contributes to the development of regional tools and leads the development of work instructions and SOPs as required

Essential Functions of the job:

Regional Leadership Leads 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 study

Leads external vendors involved in study delivery on a regional level

Collaborates 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 required

Represents the regional study team at internal meetings and at the cross-functional Clinical Study Team (CST) meetings

Leads regional operations meetings with all regional study team members

Displays therapeutic area knowledge and expertise

Timelines, Planning and Execution Leads planning and management of the assigned clinical study(ies) from feasibility through closeout activities for region, in line with global study timelines

Generates, manages, and maintains high quality study start up and recruitment timelines for region and tracks progress towards these

Ensures 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 stakeholders

Provides regional input on global study plans as required

Ensures 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 affairs

Ensures regional and country information in study systems and tools is entered and up to date Collaborates closely with CRAs in the region to ensure proper study execution at the sites. Reviews and signs-off monitoring reports

Responsible 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 plan Provides 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 region

Manages the trial data collection process for the region, drives data entry and query resolution

As required, supports planning and execution of the Clinical Study Report in collaboration with Global Clinical Study Manager and Medical Writing Quality:

Handles escalated issues or problems with the sites in region in close collaboration with stakeholders such as country heads

Monitors study activities in region to ensure…