"Alerted.org

General Description:

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

+ 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

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 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

Planning and Execution

+ Leads planning and management of the assigned clinical study(ies) from feasibility through closeout activities

+ Generates, manages, maintains, and communicates high quality study timelines and tracks progress towards these

+ Ensures that the clinical studies are operationally feasible, 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 (eg project management plan, monitoring plan, Trial Master File plan, data monitoring plan, ...) are created, updated and distributed timely and implemented appropriately

+ Ensures study systems and tools are set up timely, correctly and are functioning properly. Ensures study level information is updated on an ongoing basis in all systems

+ Ensures relevant study specific training is developed and implemented and ensures training records are well documented and filed

+ Ensures Trial Master File for 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 and timely delivery of supplies to sites

+ Supports and as needed drives overall data cleaning timelines in close collaboration with Data Management and other stakeholders (including but not limited to regional clinical operations teams and medicator monitor)

+ Ensures planning and execution of the Clinical Study Report in collaboration with Medical Writing and relevant CST members

Quality and Risk Management

+ Monitors study activities to ensure compliance with the study protocol, SOPs, ICH/GCP and all other relevant regulations

+ Ensures inspection readiness at any point in time throughout the study life cycle

+ Works with cross-functional study team to identify, interpret, and evaluate issues on the study and ensures corrective and preventative actions are implemented

+ Ensures senior management and other key stakeholders are informed of risks and challenges and ensures risk mitigation plans are put in place and implemented

+ Prepares team for quality assurance audits and inspections

+ Collaborates with CST members and other colleagues to ensure cross-team, site learnings, and best practices are shared

+ Leads improvements and partners with study team members to enhance the efficiency and the quality of the work performed on assigned studies

+ Leads development, optimization and review of work instructions and SOPs as required

Budget and Resources

+ Works with the sourcing team to select and manage study vendors, approving invoice payment throughout the study

+ Manages study budgets, including baseline budget evaluation, change control, study closure budget, budget endorsement by senior management

+ Adheres to clinical study budgeting processes and provides input to finance on budget accruals and forecasts

+ Identifies and manages study team resource needs and establishes contingency plans for key resources.

+ Monitors resource utilization over the study life cycle

+ Ensures clinical studies at a project level are executed within endorsed time, quality, and cost parameters

Supervisory Responsibilities:

+ Provides performance feedback on team members as required

+ Mentors more junior team members and might take on line management responsibilities as required

Computer Skills:

MS Office, Project Planning Applications

Other Qualifications:

+ In depth knowledge of clinical operations methodologies, in depth understanding of all aspects of clinical study processes

+ Able to independently lead large and/or complex global clinical studies

+ 8 or more years of progressive experience in clinical research within biotech, pharma or CRO industry

+ Proven project management experience

Travel:

Limited travel required

**Education Required:** Bachelor’s Degree in a scientific or healthcare discipline required* + 7 years of relevant clinical research experience. Higher Degree preferred.

_*Exceptions might be made for candidates with relevant clinical operations experience_

All 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.