Leads and directs clinical operations personnel responsible for management and delivery of clinical trials. This includes, but is not limited to ensuring cost, quality, and timeliness of multiple programs are met.
Working in a matrix organization, ensures that study objectives are in line with the clinical development strategy and the overall corporate goals.
Provides expert input into the building of department infrastructure, including developing, training, and retaining the clinical operations team; ensures prioritization of activities and resourcing is in line with clinical development programs.
Ensures that external vendors are selected and managed to deliver within established timelines and budget. This also includes site qualification, initiation, and management.
Oversee the execution of the operational strategy by external vendors; effectively lead the study through vendor oversight
Drives the creation/maintenance of clinical operations Standard Operating Procedures (SOPs), systems, and processes across the trials; ensures compliance with regulatory and other applicable standards and guidelines.
Builds collaborative relationships with key internal stakeholders including Clinical Development, Regulatory Affairs, IT, Legal, Finance departments, and project teams as needed to support clinical programs.
Collaborate with KOLs for feedback on study protocols and development plans, if required
Fosters a highly collaborative culture and serves as a leadership role model within the company and with external stakeholders.
Bachelor’s degree with 10+ years’ experience, in clinical and drug development in the pharmaceutical/biotech industry, or Master’s degree with 3+ years’ experience, or PhD degree
5+ years of global study or program management strongly preferred
Previous line management responsibilities of clinical project manager / trial leaders preferred
Understanding of drug development and program management from pre-IND through NDA; Experience monitoring clinical studies and conducting PSVs, SIVs, IMVs, and COVs required; Experience in Oncology preferred
Proven ability to build strong relationships with external partners, CROs, and vendors including extensive experience managing contracts and clinical finance activities.
In-depth, working knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
Ability to work independently and collaboratively in a fast-paced, matrixed, team environment consisting of internal and external team members.
Analytical thinker with excellent problem solving skills and the ability to adapt to changing priorities and deadlines.
Excellent verbal and written communication skills.
Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
Flexibility to travel domestically and internationally as required.
Strong working knowledge of MS Project and developing Gantt charts
While performing the duties the employee is:
1. constantly required to sit, and to reach to use computers and other office equipment
2. occasionally stand for extended periods of time, up to four (4) hours/time.
3. occasionally required to lift up to 10 pounds
4. constantly required to view objects at close and distant ranges
5. frequently required to communicate with others