Senior Manager Clinical Operations
Devoted HealthSalary not specified
Full Time
Senior (5 to 8 years), Expert & Leadership (9+ years)
Not SpecifiedCompensation
Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level
Full TimeJob Type
UnknownVisa
Clinical Research, Biotechnology, PharmaceuticalsIndustries
Requirements
- Bachelor's degree or equivalent and relevant formal academic/vocational qualification
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 10+ years) or equivalent combination of education, training, & experience
- 5+ years of management responsibility
- Proven leadership skills
- Start up and FSP experience (mandatory)
- Experience with managing people based in other countries
- Thorough knowledge of GMP, GCP or GLP
- In-depth knowledge of clinical laboratory science, ICH guidelines, FDA regulations concerning clinical labs processes in drug development process, method development, method validation, R&D, sample production and/or data processing
- Demonstrate behaviors which align to the 4i Values of Thermo Fisher
- In some cases, an equivalency consisting of a combination of appropriate education, training and/or directly related experience
Responsibilities
- Supervises and assists line leaders and high-level individual contributors with tasks such as resource management, technical and compliance related issues
- Plans, directs and implements improvements in systems, processes and procedures to increase efficiency, productivity and quality in the laboratory
- Assists the division director in strategic planning, business development, expansion initiatives, and resource allocation
- Interacts with clients, business managers and business development on requests for proposals and project definition
- Prepares, reviews and approves bids and proposals, scope of work and pricing
- Negotiates with clients on timelines and pricing
- Manages work responsibilities of line leaders as well as prioritizes communications and resources
- Reviews and approves laboratory investigation, deviations, and QA facility and data audits
- Leads client and regulatory audits
- Prepares and updates revenue projection reports, ensures accurate revenue recognition and billing, provides 6 to 12 month capacity plans for department, and drives project profitability
- Assists upper management in strategic planning, budgeting, new capabilities development and other responsibilities
- Prepares and implements PPD SOPs and company operational policies; ensures adherence and makes recommendations to quality system improvements
- Directs work responsibilities of line leaders/high level individual contributors; provides mentorship, guidance and development to team members
- Procures and allocates analytical instrumentation, Information Technology, space and other resources to appropriate areas based on business need
- Supports laboratory department in method/instrumentation troubleshooting, laboratory investigations and internal/external conflict resolution
- Collaborates globally to foster cooperation and understanding among the different functional groups within the division
- Oversees the development and implementation of laboratory systems and processes
Skills
Key technologies and capabilities for this role
Questions & Answers
Common questions about this position
What is the work schedule and location for this role?
This is a full-time position with a standard Monday-Friday schedule in an office environment.
What education is required for this Senior Mgr Clin Ops position?
A Bachelor's degree or equivalent and relevant formal education is required.
What are the main responsibilities of this role?
The role involves supervising line leaders, managing resources, interacting with clients on proposals and pricing, leading audits, preparing revenue projections, and providing mentorship to team members.
What is the company culture like at Thermo Fisher Scientific?
The company emphasizes meaningful work with global impact, enabling customers to make the world healthier, cleaner, and safer, while providing resources for individual career goals and fostering collaboration across functional groups.
What makes a strong candidate for this position?
Strong candidates will have experience in clinical operations leadership, resource management, client negotiations, regulatory compliance, strategic planning, and the ability to mentor teams and drive process improvements.
Thermo Fisher Scientific
Provides life sciences products and services
About Thermo Fisher Scientific
Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.
Waltham, MassachusettsHeadquarters
1956Year Founded
$17MTotal Funding
IPOCompany Stage
Biotechnology, HealthcareIndustries
10,001+Employees
Risks
Increased competition in single-use bioprocessing may impact market share.
Sale of anatomical pathology business could create a temporary product gap.
Investment in miDiagnostics may face regulatory challenges affecting returns.
Differentiation
Thermo Fisher offers a comprehensive range of life sciences products and services.
Their well-known brands include Thermo Scientific, Applied Biosystems, and Invitrogen.
They provide strong customer support and educational resources to optimize client workflows.
Upsides
Expansion of biologics production facility enhances capacity for precision biologics monitoring.
Investment in miDiagnostics aligns with demand for rapid diagnostic solutions in BioPharma.
Collaboration with Mainz Biomed positions them in the growing cancer detection market.
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