Clinical Team Manager/Sr. (CTM) - FSP

Thermo Fisher Scientific•Morrisville, NC

14h

About The Position

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.

Requirements

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.
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

Responsibilities

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

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.

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