Director, Clinical Operations - FSP

Posted 5 Days Ago
Be an Early Applicant
Hiring Remotely in North Carolina
Remote
Senior level
Biotech
Our Mission is to enable our customers to make the world healthier, cleaner and safer.
The Role
As Director of Clinical Operations, you will lead and manage clinical study deliverables, train staff, and ensure project completion and resource utilization align with goals.
Summary Generated by Built In

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Join Us as Director Clinical Operations – Make an Impact at the Forefront of Innovation

We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.
As part of our expert team, you’ll have the opportunity to ensure operational excellence that makes a real difference in organizational performance. As Director Clinical Operations, you will provide strategic direction, leadership, and management within an area of a region to secure the successful completion of clinical deliverables within assigned studies. This includes training and managing staff to contribute to the successful delivery of clean data from evaluable patients within project parameters of time, quality, and cost. You will provide direct supervision, support, training, and mentoring to your staff regarding all general aspects of the Clinical Team Manager (CTM) and Clinical Manager roles. You will be responsible for performance assessments and annual reviews of your direct reports.
You will assist in resource utilization, policy development, and implementation of goals by working with leadership in all functional areas on the continuous development of business processes to support cross-functional teams, ensuring work is uniform, complete, and managed appropriately within the assigned functional area. In developing regions, your responsibilities may include oversight of all deliverables within a country/region, including participation in business development activities.
What You’ll Do:
• Supervise and coordinate departmental functions, including mentoring managers in day-to-day activities and responsibilities related to the clinical deliverables. Ensure the clinical teams are provided with the necessary support and resources to successfully deliver clinical deliverables, e.g., oversee study start-up, monitoring and site management deliverables. At a country level, may liaise with other functional departments to ensure delivery of projects to clients and contribute to feasibility projects
• Ensure the timely execution of clinical deliverables with a focus on quality deliverables. In those cases, develop and drive the specific and overall projector program strategies to ensure optimum performance and achievement of annual plans and targets. Facilitate meetings to identify potential risks and work with the clinical team to develop and communicate contingency plans. Ensure risks to clinical deliverables and potential solutions are communicated through appropriate escalation pathways. Review and assess clinical project or program finances and ensure risks are escalated appropriately with any information necessary for a contract modification
• Manage department resource levels including hiring and promoting, as appropriate. Participate in resource calls and ensure teams are provided with adequate levels of appropriately qualified resources
• Induct new managers to PPD. Provides performance appraisals, evaluate and allocate bonuses and merit increases, as appropriate. Develop and motivates through goal setting, ongoing feedback, formal evaluation, and effective delegation of decision making. Ensure staff is trained and mentored according to company policies and procedures. Develop, implement and review key performance metrics
• Manage the overall budgeting activity of the assigned group(s) - annual and long-range forecast
• Participate in global and/or cross-functional initiatives and process improvement projects
Education and Experience Requirements:
• Bachelor's Degree in a science related field.
• Significant clinical research experience (comparable to 12+ years) including remote and clinical monitoring and experience in all phases of study life cycle, including start up, interim and close out.
• Line management experience appropriate to the size and complexity of the clinical management group in the designated country/region.
• Strong leadership skills.
• Valid Driver's License.
• Valid Passport.

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills and Abilities:
• Advanced leadership and management skills
• Excellent judgment and decision making skills
• Excellent interpersonal and problem solving ability
• Expertise in negotiating and strong organizational skills
• Excellent oral/presentation and written communication skills in the native language and in English
• Ability to perform tasks required of a functional staff
• Ability to successfully network with other Divisions (departments) where necessary
• Strong knowledge of budgeting, forecasting and fiscal management
• Demonstrated expertise in leading, motivating and integrating project teams
• Self-motivated and possess good interpersonal skills and projects a positive attitude
• Ability to effectively teach required skills
• Excellent coaching and mentoring skills
• Knowledge and understanding of clinical development regulatory guidelines and Directives
• Ability to work effectively in a matrix organization
Working Conditions and Environment:
• Work is performed in an office environment with exposure to electrical office equipment.
• Occasional drives to site locations, frequent travels both domestic and international.
Why Join Us?
When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference.
Apply today to help us deliver tomorrow’s breakthroughs.

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The Company
HQ: Waltham, MA
100,000 Employees

What We Do

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.

Why Work With Us

You will join a company which every colleague has the opportunity to create possibilities, for oneself, for our customers and patients. There is no more exciting place to be than at the forefront of solving problems which help improve lives around the world. As a company, we are committed to supporting your career aspirations and your journey.

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