Reporting to the Associate Director of Technical Operations, the Technical Operations Manager will work with a cross-functional team of internal stakeholders (Clinical Operations, Data Management, Biostatistics, Clinical Supply, QA, Outsourcing, and Clinical Science) and medical imaging suppliers to support Exelixis clinical trials.
Assist with conducting training on standards, processes and metrics for the consistent conduct of Exelixis trials.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Assists in tracking the collection and submission of radiographic images from study sites to a CRO or an independent radiology committee.
Provide imaging protocol deviation surveillance oversight as well as SOP change management and deviation surveillance.
To ensure that Data Protection Act is applied to all subject data and that subject confidentiality is maintained at all times.
Plan and coordinate imaging site start-up activities.
Collaborate and assist with CRO and Imaging supplier(s) in the monitoring and resolution of data discrepancies.
Lead or assist with the governance and oversight of imaging suppliers.
Monitor cross-study technical and operational supplier performance and manage escalated issues to resolution.
Manage communication and expectations between the study team, internal stakeholders and imaging supplier(s).
To be responsible for: establishing quality standards, investigating compliance in a timely and efficient manner, implementing service improvement plans when required.
Work to identify metrics and solution for trend analysis of potential and current issues.
To have regular communication with other Heads of Department to provide a cohesive approach to clinical service delivery.
Reading and understanding project protocol documents.
Participating in project meetings, conference calls, and training calls.
Support records retention management.
BS/BA degree in related discipline and seven years of related experience; or,
MS/MA degree in related discipline and five years of related experience; or,
PhD in related discipline and three years of related experience; or,
Equivalent combination of education and experience.
May require certification in assigned area.
Experience in clinical operations, supplier management, and cross-functional team leadership required.
Experience in Biotech/Pharmaceutical industry preferred.
Experience in Imaging Supplier preferred.
Experience in radiographic imaging in a clinical environment preferred.
Experience in RECIST 1.1 preferred.
Extensive experience in relevant industry/profession.
Knowledgeable in Good Clinical Practice and FDA regulations.
Broad expertise or unique knowledge and skills to contribute to development of company objectives and principles and to achieve goals in creative and effective ways.
Knowledge of the drug development/clinical trials process/basic clinical research and/or experience working in a pharmaceutical environment preferred.
Development of technical and/or business solutions to complex problems.
Identifies and implements methods, techniques, procedures and evaluation criteria to achieve results.
Performs a variety of complicated tasks with a wide degree of creativity and latitude.
Has complete understanding and wide application of technical principles, theories, concepts and techniques.
Proficient in Visio, PowerPoint, Excel, Project and Word.
Ability to communicate complex technical issues to non-technical stakeholders.
Works on significant and unique issues where analysis of situations or data requires an evaluation of intangibles.
Exercises independent judgment in methods, techniques and evaluation of criteria for obtaining results.
Creates formal networks involving coordination among groups.
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.