Manager Amendment Implementation
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Job Location:
Monthly Salary:
Posted on:
17 hours ago
Vacancies:
1 Vacancy
Job Summary
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
Manager Amendment Implementation
Summarized Purpose:Leads and manages a team of employees responsible for the successful completion of amendment implementation deliverables within assigned studies; May manage and/or serve as a mentor to junior managers or acting as the lead manager; Responsible for oversight and execution of amendments to ensure the achievement of departmental goals; Works with the resourcing team and other PSS people managers to meet resourcing needs and amendment implementation deliverables determining strategy using advanced negotiation skills when needed.
Essential Functions:
Primary focus is on people and performance management of team members with a secondary focus on operational management of amendment implementation
Acts as point-of-escalation regarding performance concerns and training needs to ensure adherence to the companys SOPs and policies
Serves as positive leadership and professional role model for all staff providing direct coaching and development support to their operational teams
Collaborates with management and executive staff in various Clinical Development Services Division (CDSD) departments (e.g. Project Delivery Clinical Operations etc.) on tasks initiatives or workstreams of moderate complexity as required
Works in collaboration with the resourcing team other PSS people managers and study managers to meet resourcing needs and amendment deliverables/milestones determining strategy and using moderate negotiation skills when needed
Approves courses of action on salary administration hiring corrective action and terminations
Reviews and approves time records expense reports requests for leave and overtime
Ensures initiatives are implemented to ensure efficiency in proposed processes consistency in execution and quality output
Performs any other duties and projects as assigned by leadership
Education & Experience
Bachelors degree or equivalent and relevant formal academic/vocational qualification
Previous experience that provides the knowledge skills and abilities to perform the job (comparable to 5 years) 1 year of leadership responsibility
Knowledge Skills and Abilities
Solid knowledge of ICH GCP applicable regulations and Company/Client procedural documents
Advanced knowledge in all phases of clinical trials specifically study startup study maintenance and study close out
Advanced skills in managing engaging motivating mentoring and retaining staff
Strong knowledge of budgets projects and metrics (financial and business acumen)
Ability to handle multiple tasks simultaneously to meet rigorous timelines and to work effectively in stressful situations
Excellent organizational strategic and negotiation skills and strong attention to detail
Excellent communication skills both written and verbal including strong command of English and excellent interpersonal and conflict resolution skills
Ability to travel if required
Ability to utilize problem-solving techniques applicable to a constantly changing environment
Management Role: Manages experienced professionals and/or subordinate management who exercise latitude and independence in their assignments.
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 Abilities:
Demonstrated effective mentoring/leadership/supervisory ability including excellent interpersonal skills
Capable of motivating individuals/teams and proactively addressing and managing performance issues
Excellent clinical trials monitoring skills
Expert knowledge of relevant regulations and guidelines
Demonstrated ability to evaluate medical research data and demonstrate proficient knowledge of medical terminology
Effective organizational and negotiation skills
Strong attention to detail
Effective written and oral communication skills
Good knowledge of English language and grammar
Competent use of computer to include data entry archival and retrieval
Strong team player with team building skills
Strong interpersonal and conflict resolution skills
Utilize problem-solving techniques applicable to constantly changing environment
Proficient knowledge of medical/therapeutic areas
Working Conditions and Environment:
Work is performed in an office environment with exposure to electrical office equipment.
Frequently drives to site locations and frequently 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. Youll work in an environment where collaboration and development are part of the everyday experienceand where your contributions truly make a difference.
Apply today to help us deliver tomorrows breakthroughs.
Required Experience:
Manager
Key Skills
- Business Development
- Project Timelines
- Business Process
- Customer Service
- Client Expectations
- Account Management
- Salesforce
- Client Relationships
- Project Management
- ERP
- Java
- Client Service
- Consultants
- Management System
- Procedures
About Company
Electron microscopes reveal hidden wonders that are smaller than the human eye can see. They fire electrons and create images, magnifying micrometer and nanometer structures by up to ten million times, providing a spectacular level of detail, even allowing researchers to view single a ... View more
