Senior Director Clinical Operations 1061788
Job Scope & Purpose:
Our established client is seeking an experienced Sr. Director, Clinical Operations to be responsible for the Clinical Operations strategy, execution and management of assigned global clinical program(s) in support of the Clinical Development Plan (CDP). The Sr. Director, Clinical Operations will independently plan and manage cross functional activities in order to ensure individual, departmental and corporate goals and objectives are met on time, with quality and within budget. He/she will provide Clinical Operations expertise in cross-functional meetings and will work closely with cross functional members to ensure the quality and in accordance with the company’s SOPs and ICH guidelines. The successful candidate will develop and implement department processes and initiatives and will have line management responsibility for other Clinical Operations teams members. This role will have multiple clinical operations direct reports at varying levels, e.g., Clinical Operations Program Managers and Clinical Operations Study Leads. Responsibilities include professional development, performance appraisals, and employee counseling. This role reports to the Head of Clinical Operations
Primary Job Responsibilities:
- Responsible for the operational strategy and overall execution of assigned clinical program(s) which includes focus on budget, timelines, quality, resource management and providing operational strategies in support of achieving clinical program objectives.
- Develop and actively manage clinical trial recruitment strategies with evaluation of actual enrollment against assigned targets and working with investigational sites to meet, and whenever feasible, exceed enrollment targets. Ensures compliance with SOP’s, GCP and ICH guidelines.
- Develop and coordinate operational plans for a clinical study or multiple clinical studies within a development program (i.e. study timeline projection, drug and budget forecast, safety plan, monitoring plan, study management plan, issue escalation and resolution plan).
- Lead the Clinical Operation team(s) including in-house team members and Contract Research Organizations (CROs), vendors and other suppliers to ensure work quality, timeliness and adherence to budget.
- Responsible for the selection, oversight and performance of CROs, Contract Laboratories and other vendors for assigned programs.
- Represent the company at clinical sites and external project meetings as required.
- Responsible for the clinical section and overall development update for annual report and IB.
- Direct and manage Clinical Operations financial planning/forecasting and budget management and monitor the budget against actuals.
Primary Job Requirements:
- B.A./B.S. in a science, RN, Pharma D / Master’s degree preferred
- 12+ years of experience in clinical research in the pharmaceutical industry, including 9+ years clinical study/program management; program management experience required
- Experience in setup, execution and operational management of domestic and international Phase 1, 2, and 3 clinical trials across an array of therapeutic areas. Experience as a program manager ensuring program timelines are achieved
- Good understanding of clinical study implementation process
- Must be able to review clinical study tables and listings to ensure clinical data integrity
- Productivity/Organizing/Planning – Must be proactive and self-disciplined and meets deadlines, demonstrates effective use of time, and handles multiple assignments simultaneously. Ability to organize and manage multiple priorities: your own and those of work teams you oversee and support
- Independent decision-making and analytical skills are required.
Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.
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Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us.
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Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at [ Phone number blocked ]