




**Work Schedule** Standard (Mon\-Fri)**Environmental Conditions** Office**Job Description** Job 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 company's 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** * **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 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. 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.


