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COM

Life Technologies SAS
🇨🇳 China
On-site
Staff / Principal
2 months ago
  • ICH-GCP
  • medical terminology

Not enough detail in this posting to match

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

AtThermo Fisher Scientific,you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier,cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research,development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spanslaboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.  

Summarized Purpose:  

Manages, selects, trains, resources,coaches and performance management of respective staff, which may be inclusive of CAS, CS, CRAs, PAs, RSMs and/or other clinical operations focused staff. Focuses on end results using metrics and key performance indicators to manage performance. May lead or contribute to initiatives that improve the department's performance or lead to process improvement across the company. Collaborates with clinical operations senior management and executive staff on strategic planning and business development asrequired. Acts as point-of-escalationregarding performance concerns and training needs to ensure adherence to the company's SOPs and WPDs. Works in collaboration with the leadership team for resourcing needs.  

Key responsibilities: 

  • Manages staff, providing coaching,mentorship and work direction. 

  • Conducts regular performance appraisals and career discussions with staff. Facilitates employee career development. Interviews,recruits and selects staff. 

  • Manages and conductsinduction/orientation programs for all new employees, ensuring their smooth assimilation into the company. 

  • Ensures all staff CVs, training records, position profiles and experience profiles are complete andup-to-date. Ensures timeliness and accuracy of timesheets and expense reports. 

  • Supports allocation activities per the local resourcing process. Supports activities of project leads/functional leads tooptimize the operational running of projects. Escalates appropriately any issues which mayimpact project deliverables. 

  • Delivers training on Working Practice Documents (WPDs) and Standard Operating Procedures (SOPs), local requirements and any other subjects thatimpact on clinical operations.Identifies training gaps and ensures that training requirements are met. May contribute todevelopment of training programs, whereappropriate. 

  • Assures adherence to good ethical and regulatory standards. 

  • Alerts management to quality issues, request QA audits asappropriate, andfacilitate client and internal quality assurance audits asrequired. 

  • Manages and reviews systems (e.g. Activate, CTMS,Preclarus, Clarity) to evaluate employee and project metrics, KPIs and general project status. 

  • Evaluates work of staff, including conducting PAVs (either remote or on-site) to thoroughly evaluate theemployee supervising skills and project conduction when applicable. 

  • Participates in processimprovement/development initiatives. 

  • Ensures understanding and facilitation of therisk based monitoring approach. 

  • May provide input into bids and contribute to the procurement of new business whererequired. 

Keys to Success 

Education and 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:  

  • Sophisticatedmentoring/leadership/supervisory skills 

  • Excellent clinical trials monitoring skills; Remote and on-site 

  • Demonstrated understanding of or ability to learn the company’s SOPs, WPDs, and relevant regulations (e.g. ICH/GCP, FDA guidelines) 

  • Demonstrated ability to evaluate medical research data 

  • Strong organizational and negotiation skills 

  • Strong attention to detail 

  • Sophisticated written and oral communication skills 

  • Good knowledge of English language and grammar 

  • Demonstrated use of computer to include data entry, archival and retrieval 

  • Ability to travel as needed 

  • Excellent team player with team building skills 

  • Excellent interpersonal and conflict resolution skills 

  • Sophisticated ability toutilize problem-solving techniques applicable to constantly changing environment 

  • Solid knowledge of medical/therapeutic areas and medical terminology 

Benefits 

We offer competitiveremuneration, annual incentive planbonus, healthcare, and a range of employee benefits.Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation! 

Our Mission is to enable our customers to make the world healthier,cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity,Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technologicalinnovation and support patients in need. #StartYourStory with PPD, part ofThermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.  

Apply today!http://jobs.thermofisher.com 

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminateon the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status,disability or any other legally protected status. 

Accessibility/Disability Access 

Job Seekers with a Disability:Thermo Fisher Scientific offers accessibilityservice for job seekers requiringaccommodations in the job application process. For example, this may include individualsrequiringassistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, orassisting a person with a disability, and require accessibilityassistance oran accommodation to apply for one of our jobs, pleasesubmit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process. 

*This telephone line is reserved solely for job seekers with disabilities requiring accessibilityassistance oran accommodation in the job application process. Messages left for other purposes, such as not being able to getinto the career website, following up on an application, or other non-disability related technicalissues will not receive a response. 

COM · Life Technologies SAS

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