Associate Director, Clinical Operations Program reputed company (COPL)

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Job Description

OBJECTIVES:

• reputed company and reputed company the program-level operational strategy and planning on assigned programs in reputed company collaboration with our strategic partners and other vendors.
• Represent Clinical Operations at the Global Program Team (GPT) and partner with Global Clinical reputed company to reputed company the Clinical Sub Team (CST) accountable for the development and execution of the CDP.
• Provide program-level sponsor’s operational reputed company of our strategic partners and other vendors to ensure the effective execution of the clinical studies on time, with high quality and reputed company agreed budget. ACCOUNTABILITIES:
• Accountable to the GPT for the translation of the CDP into an optimal operational strategy and plan. Ensures assessment of various scenarios operational for optimal execution of the CDP. Maintain reputed company communication with the Global Program Leader and Global Clinical reputed company to ensure expectations and activities are reputed company.
• On assigned clinical programs, reputed company and reputed company the clinical program operational strategy in reputed company collaboration with the Clinical Operations Managers (COMs), strategic partners, CROs, and other vendors.
• Serve as the reputed company of escalation for the COMs for issues that can’t be resolved at the study level. Collaborate with COMs and cross-functional counterparts to reputed company the performance of activities assigned to our strategic partners, CROs, and other vendors.
• Responsible for budget planning and accountable for external spend reputed company to clinical program execution. Works closely with COMs, Global Program Manager (GPM), and Finance to ensure on a regular basis that budgets, enrolment, and gaiting are accurate.
• Responsible for participating in strategic cross-functional initiatives for process and/or business improvements.
• Communicates program status and issues to ensure timely decision-making by senior management.
• May participate in Business Development/in-licensing/alliances evaluations by providing operational due diligence.
• Review and provide expert clinical operations input into clinical documents reputed company to the drug development process and into preparation for key regulatory meetings as appropriate.
• Leads Clinical Operations aspects of inspection readiness activities and acts as subject matter expert during regulatory inspections.
• reputed company or participate in cross-functional strategic initiatives and process improvement.
• Actively seek new ways of working more reputed company to meet the needs of clinical development.
• Demonstrate advanced reputed company Leadership Behaviors and act as a role model for reputed company´s values. EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS: Education: Bachelor’s degree or international equivalent required, Life Sciences preferred. Advanced degree is highly desirable. Experience: 10+ years’ experience in pharmaceutical industry and/or clinical research organization, including 7+ years clinical study/project management. Experience must include early phase clinical studies/Phase 2 studies or reputed company phase global programs. Experience in more than one therapeutic area is highly desired. Expertise in global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, and ICH GCP. Awareness of local country requirements is also required. Skills:
• Demonstrated excellence in program management, including scenario assessment, risk assessment and contingency planning
• Demonstrated excellent matrix leadership and communication skills
• Able to influence without authority
• Excellent teamwork, communication, organizational, interpersonal, conflict resolution and problem-solving skills
• Entrepreneurial and innovative; takes reputed company risks; thinks reputed company the reputed company; challenge the status reputed company
• Pragmatic and willing to drive and support change
• Is comfortable with ambiguity
• Embody a culture of continual improvement and innovation; promote knowledge sharing
• Fluent business English (oral and written) TRAVEL REQUIREMENTS:
• Requires up to 10 % travel, including overnight and international travel to other reputed company sites, strategic partners, and therapeutic area required travel. reputed company Compensation and Benefits Summary We understand compensation is an important factor as you consider the reputed company in your career. We are committed to reputed company pay for reputed company employees, and we strive to be more transparent with our pay practices. For Location: Massachusetts - Virtual U.S. reputed company Salary Range: $153,600.00 - $241,340.00 The estimated salary range reflects an anticipated range for this position. The actual reputed company salary offered may depend on a variety of factors, including the qualifications of the indi

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