Associate Director, Clinical-Columbus Oh/Berkeley Heights NJ

Associate Director, Clinical

 

Overview

Lead with project plan development for clinical research trials.  Manage internal and external resources including subject matter experts, doctors, vendors, and drive activities to meet or exceed timelines and milestones.  Identify obstacles that may negatively impact clinical trial progress and ideate viable options to maintain project advancement.

 

Responsibilities

Clinical Research Trial management:

• Direct and manage the clinical trial project from beginning to end.  Responsible and accountable for the delivery of project milestones, and maintaining timelines to successful outcomes according to the approved business case on time, expected quality and within budget.
• Lead with defining clinical trial project scope, goals and deliverables that support business goals in collaboration with key internal and external stakeholders on an on-going basis.
• Identify and manage clinical trial project dependencies and critical path
• Proactively manage changes in project scope, identify potential crises, and devise contingency plans.
• Build, develop and grow any business relationships vital to the success of the portfolio.
• Prompt inter-departmental communication to provide clinical supplies to meet clinical trial schedule and timeline

 

Measurement:

• Key clinical trial project tasks and milestones are completed on time.  Each project stage and overall budget is managed to plan and any overages are escalated for review.

All documents are written, reviewed and subsequently approved with agreed time frames.  Changes are approved and notified to all relevant recipients.

 

Leadership in ideas to launch process

• Collaborates with internal and external resources to achieve best outcomes.
• Effectively communicates clinical trial progress and status to key stakeholders in a timely and clear fashion.
• Identify and resolve issues/conflicts with the clinical research trial project key resources.
• Proactively manage changes in project scope, identify potential crises, and devise contingency plans.
• Lead and support any regulatory needs from all US facility and Mena area

Measurement:

• Delivery in full and on time for business requirements. 
• Feedback from Senior Management, Functional Managers
• Delivery and timely manner submission of all US submission and MENA area

 

Planning and Reporting

• Lead with the development of full-scale clinical trial project plans and associated communications documents, and tracking tools.
• Estimate the resources and participants needed to achieve project goals.
• Lead with drafting the budget proposals, and recommend subsequent budget changes where necessary.
• Track clinical trial project milestones and deliverables.
• Develop and deliver progress reports, proposals, requirements documentation and presentations
• Support clinical trial project post-mortems and help create a recommendation report in order to identify successful and unsuccessful factors of the clinical trial.
• Present portfolio statistics to the gatekeepers and recommend corrective actions.  Communication is clear, comprehensive and correct.

 

Measurement:

• Ensure timely completion of all reporting and associated administrative requirements.
• Accuracy of budgets prepared and actual realized.
• Continuous improvement initiatives tabled.

Poor performance identified and escalated to appropriate level of management.

 

Relationships

• Maintain an environment of cooperation and team work.
• Interface with all related functions and teams as required.
• May serve as liaise for the clinical trial project in certain aspects of clinical research project with key internal and external contractors, client or business partners.

 

Measurement:

• Feedback from key stakeholders, internal and external subject matter experts.
• Communication and documents are accurate and distributed in a timely manner to the relevant recipients. 

Able to proactively manage and resolve conflicts that may arise.

 

Health, Safety and Security of data

• Ensure that in all circumstances, there is adherence to all environmental, health and safety guidelines and procedures in an effort to protect employees and to provide a work environment that is safety-focused.
• Ensure that any data generated by hikma sponsored trials is well protected and properly communicated

 

Measurement:

• No preventable accidents, no lost time injuries

Compliance with data management in GCP