Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
At Thermo 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 spans laboratory, 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:
Accountable for achieving the final clinical deliverable (usually clean data from evaluable patients as specified in the study protocol) within the time period specified in the contract with the customer. Interprets data on complex issues and makes good business decisions with support from line management. Works to ensure that all clinical deliverables meet the customer's time/quality/cost expectations. Maintains profitability by ensuring clinical activity is conducted within contract scope, through efficient management of the clinical team. Typically works independently on projects of moderate to high complexity, and may assume regional lead or Clinical Study Manager responsibilities.
Essential Functions:
- Manages all aspects of monitoring operations and quality for assigned studies, ensuring compliance with ICH GCP and applicable local regulations
- Develops clinical tools and study plans, collaborates with Biogen CSO (to include but not limited to CCSLs) and leads team meetings to maintain timelines, resources, and quality. Serves as clinical subject matter expert for protocol and point of escalation for site manager as applicable
- May include reginal coordination with regional CMLs.
- Ensures timely deliverables, monitors trials, communicates with study sites, coordinates start-up activities, addresses regulatory requirements and provides input on forecast estimates and resource management.
- Completes trip report reviews in compliance with study plan timeline.
- Issue escalation per plan, responsible for identifying and reporting site performance issues, trend analysis
- May perform accompanied site visits with site manager and may attend meetings with Sponsor to discuss, but not limited to country/region start up progress, trending and issue identification/escalation, and general site/country updates.
- Generate monitoring plan and trip report completion annotations
Education and Experience:
- Bachelor's degree and previous experience comparable to 5+ years.
- Monitoring or Study Management, and Oversight experience preferred.
- Extensive Neuroscience experience preferred.
- Prior client-dedicated experience preferred.
Knowledge, Skills and Abilities:
- Advanced mentoring/leadership/supervisory skills
- Excellent clinical trials monitoring skills; ideally remote AND onsite experience
- Demonstrated understanding of or ability to learn the company’s SOPs, WPDs, and relevant regulations (e.g. ICH/GCP, FDA guidelines)
- Strong organizational and negotiation skills
- Strong attention to detail
- Advanced written and oral communication skills
- Strong 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
- Advanced ability to utilize problem-solving techniques applicable to constantly changing environment
- Solid knowledge of medical/therapeutic areas and medical terminology
Working Environment:
- PPD, a part of Thermo Fisher Scientific, values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:
- Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
- Able to work upright and stationary for typical working hours.
- Able to work in non-traditional work environments.
- Able to use and learn standard office equipment and technology with proficiency.
- Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
- May have exposure to potentially hazardous elements typically found in healthcare or laboratory environments.
- This role requires independent travel up to 20%, inclusive of traveling in automobiles, airplanes, and trains.
Our 4i Values:
- Integrity – Innovation – Intensity – Involvement
- If you resonate with our 4i values above and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, submit your application – we’d love to hear from you!
Benefits
We offer competitive remuneration, annual incentive plan bonus, 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!
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Originally posted on Himalayas