Associate Director, Global Clinical Study Management

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.
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* General Description:

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* · Accountable for global study delivery within agreed timelines and budget with appropriate inspection readiness quality
· Leads all aspects of assigned clinical study(ies)
· Leads global cross-functional study team (including oversight of external partners) and acts as point of escalation for resolution of issues within assigned study(ies)
· Ensures alignment of study goals with clinical operations and corporate goals and objectives
· Contributes to development of global tools and standards, leads the development of work instructions and SOPs as required
· Provides technical coaching and/or mentoring to junior team members and partners.
** Essential Functions of the job:
**** Cross-Functional Leadership*
* · Leads the global cross-functional study team effectively, ensures effective decision making, and acts as point of escalation for resolution of study related issues
· Leads external vendors management involved in study delivery
· Builds trust and relationship with regional subject matter experts and supports the delivery of their local study objectives
· Collaborates with key stakeholders across the organization and provides regular updates on study progress to senior management as required
· Represents the study team at internal meetings and leads the cross-functional Clinical Study Team (CST) meetings
· Participates and presents at various topics of Clinical Study Management
· Participates in Clinical Operations Process improvement initiative
** Planning and Execution*
* · Leads planning and management of the assigned clinical study(ies) from feasibility through closeout activities, including large and/or complex global clinical studies from early phase/dose escalation studies to phase III registration studies based on business needs.
· Serves as a strategic advocate for projects, offering innovative operational solutions to address risks and challenges, including active involvement in CDP development in collaboration with the GCPL and other key activities
· Generates, manages, maintains, and communicates high-quality study timelines and tracks progress toward these.
· Ensures that the clinical studies are operationally feasible along with GCPL , oversees trial feasibility, trial allocation, and site selection process across all regions.
· Ensures timely availability of high-quality study documents to allow study submission to regulatory authorities and ECs/IRBs.
· Provides oversight to study start-up and site activation plans.
· Ensures study plans (e.g., project management plan, monitoring plan, Trial Master File plan, data monitoring plan, etc.) are created, updated, and distributed timely and implemented appropriately
· Ensures study systems and tools are set up in a timely and correct manner and are functioning correctly. Ensures study-level information is updated on an ongoing basis in all systems.
· Implements RBQM end-to-end processes on time within the allocated study (e.g., periodic reviews, centralized monitoring analyses, action items)
· Ensures relevant study-specific training is developed and implemented and ensures training records are well documented and filed.
· Ensures Trial Master File for the study is created, maintained, and QC’d on a regular basis as per the study TMF QC plan.
· Collaborates closely with Global Clinical Supplies to forecast study drug supply and timely delivery of supplies to sites.
· Supports and as needed, drives overall data…