Providescustomer-focused leadership in managing clinical projects across variousphases, functional areas and assigned clinical staff.
Accountable for the successful execution ofall assigned projects, where success includes on-time, on-budget,high-quality / compliant project results that lead to satisfied customers.
Mayhave line management responsibilities.
Project Leadership and Delivery :
Manages a project as a project manager overseeing interdisciplinary clinical research studies and ensures compliance with GCP, relevant SOP’s, and regulatory requirements.
Acts as a primary liaison between the Company and the Customer to ensure timely study launch, conduct, and closeout according to the Customer’s and the Company’s contractual agreement.
Lead project team to ensure quality, timelines and budget management.
Accountable for the financial performance of each project.
Coordinate activities and deliverables of all study conduct partners and proactively identify and manage issues.
Ensure studies are conducted in compliance with GCP, relevant SOP’s and regulatory requirements.
Accountable for all project deliverables for each project assigned.
Documentation and Reporting :
Responsible for quality and completeness of TMF for assigned projects.
Accountable for maintenance of study information on a variety of databases and systems.
Responsible for study management components of inspection readiness for all aspects of the study conduct.
Oversight for development and implementation of project plans.
Plan, coordinate and present at internal and external meetings.
Prepare project management reports for clients and management.
Developing contingency planning and risk mitigation strategies to ensure successful delivery of study goals.
Business Development :
Develops strong relationships with current clients to generate new and / or add-on business for the future.
May participate in bid defense meetings where presented as potential project manager.
May be required to line manage other project management team members and clinical monitoring staff.
QUALIFICATION REQUIREMENTS (pleaseindicate if preferred’)
Bachelor’s Degree (or equivalent) level ofqualification in life sciences, Medicine, Pharmacy, Nursing or equivalentcombination of education and experience.
Clinical research organization (CRO) and relevanttherapeutic experience preferred.Strongknowledge of Good Clinical Practice / ICH guidelines and other applicableregulatory requirements
Strong organizational skills.
Strong ability to manage time and work independently.
Direct therapeutic area expertise.
Ability to embrace new technologies.
Excellent communication, presentation, interpersonalskills, both written and spoken.
Ability to travel as necessary (approximately 25%).
Tasks, duties, and responsibilities as listed in this jobdescription are not exhaustive. The Company, at its sole discretion and with noprior notice, may assign other tasks, duties, and job responsibilities.
Equivalent experience, skills, and / or education will also be considered soqualifications of incumbents may differ from those listed in the JobDescription.
The Company, at its sole discretion, will determine whatconstitutes as equivalent to the qualifications described above.
Further,nothing contained herein should be construed to create an employment contract.Occasionally, required skills / experiences for jobs are expressed in briefterms.
Any language contained herein is intended to fully comply with allobligations imposed by the legislation of each country in which it operates,including the implementation of the EU Equality Directive, in relation to therecruitment and employment of its employees.