Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
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.
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Our global Clinical Operations colleagues within our PPD® clinical research services provide end-to-end support for clinical trials from study start up to monitoring through to study close out, across commercial and government contracts. Together, we help clients define and develop clinical programs, minimize delays, and execute high-quality, cost-efficient clinical studies.
This role is within our FSP (Functional Service Partnership) division, which is a partnership between Thermo Fisher Scientific and one of our strategic clients. In this position, employees will be assigned to work with a specific client to carry out the responsibilities outlined below.
Summarized Purpose:
Manages, selects, trains, resources, coaches and performance management of respective staff. Focuses on end results using metrics and key performance indicators to lead performance. May lead or help to enhance the department's performance or lead to process improvement across PPD. Collaborates with clinical operations senior management and executive staff on strategic planning and business development as required. Acts as point-of-escalation regarding performance concerns and training needs to ensure adherence to PPD SOPs and WPDs. Works in collaboration with the leadership team for resourcing needs.
Discover Impactful Work:
Clinical Research Group is dedicated in improving health. It starts as an idea to cure. It becomes a life saved. All in-between, it's you! We know that meaningful results not only require the right approach, but also the right people. We invite you to re-imagine health promoting protocols with us, working alongside our dedicated, forward-thinking and upbeat teams.
Key responsibilities
- Leads 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
- Leads and conducts induction/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 and up-to-date. Ensures timeliness and accuracy of timesheets and expense reports
- Supports allocation activities per the local resourcing process. Supports activities of project managers and clinical team managers to optimize the operational running of projects.
- Delivers training on Working Practice Documents (WPDs) and Standard Operating Procedures (SOPs), local requirements and any other subjects that impact on clinical operations. Identifies training gaps and ensures that training requirements are met. May help with development of training programs, where appropriate
- Alerts management to quality issues, request QA audits as appropriate, and facilitate client and internal quality assurance audits as required
- Leads and reviews systems (e.g. CTMS, Preclarus, Clarity) to evaluate employee and project metrics, performance and general project status.
- Evaluates work of staff, including conducting PAVs (either remote or on-site) to thoroughly evaluate the employee monitoring skills and project conduction when applicable.
- Participates in process improvement/development initiatives.
- Ensures understanding and facilitation of the risk based monitoring approach.
- May provide input into bids and assist in the procurement of new business where required.
Keys to Success:
Education
- Bachelor's degree in a life sciences related field or a Registered Nursing certification or relevant formal academic / vocational qualification.
Experience
- Should have 8+ years of working experience in Clinical Monitoring related activities
- Should have 2+ years of experience in managing team of Clinical Trial Coordinators or Clinical Project Specialist
- Should have working experience in Workflow Management, Performance Management, Client/Stakeholder Management
Knowledge, Skills, Abilities
- Excellent mentoring/leadership/supervisory skills
- Knowledge of clinical trials monitoring; Remote and on-site
- Validated understanding of or ability to learn PPD SOPs, WPDs, and relevant regulations (e.g. ICH/GCP, FDA guidelines)
- Validated ability to evaluate medical research data
- Strong 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
- Ability to travel as needed
- Excellent interpersonal and conflict resolution skills
- Ability to use problem-solving techniques applicable to constantly changing environment
- Proven knowledge of medical/therapeutic areas and medical terminology