Senior CTM - Neuroscience

This is a remote Senior Clinical Team Manager role on the Neuroscience team at Thermo Fisher Scientific, posted through Lifelancer. The position is full time, standard Monday to Friday hours, and the employer lists the work as office-based with frequent travel to sites, both domestic and international. It is for an experienced clinical team manager who has run studies in ophthalmology, rare disease, or sleep, epilepsy and psychiatry.

The Senior Clinical Team Manager is accountable for the final clinical deliverable, usually clean data from evaluable patients as set out in the study protocol, within the time period in the contract with the customer. The role covers projects of low to moderate complexity and sits within a team of CTMs.

What you will do

• Manage all clinical operational and quality aspects of allocated studies, including high complexity studies, in compliance with ICH GCP. On small or less complex projects you may take on Clinical Study Manager responsibilities.
• Develop clinical tools such as the Monitoring Plan and Monitoring Guidelines alongside the Data Quality Plan, and contribute to the Master Action Plan. You will ensure the relevant sections of the Trial Master File are set up, organised and of good quality, and may help design CRFs, CRF guidelines and patient informed consent templates.
• Work with the project manager to prepare, organise and present at client meetings, including bid defense and hand-off meetings.
• Communicate regularly with the clinical team and lead team meetings so that timelines, resources, interactions and quality stay on track. You will implement and train the team on standardised clinical monitoring processes and handle timely archiving of documents and study materials.
• Prepare and monitor clinical activity timelines and metrics, give status updates to the project manager, review projects using tracking and management tools, put recovery actions in place, review monitoring visit reports, and manage CRF collection and query resolution.
• Monitor or co-monitor clinical trials to assess performance and confirm contractual obligations are met. In smaller regions you may routinely conduct Accompanied Field Visits and be accountable for project financials.
• May communicate with study sites on protocol, patient participation, case report form completion and other study issues.
• May coordinate start-up activities and ethics committee and regulatory submissions, making sure essential document quality meets Regulatory Compliance Review expectations and following up on questions from ethics committees.
• May provide input into forecast estimates for clinical activities, and manage clinical resources, assignments, delegation and identification of additional resource needs.

What they are looking for

• A bachelor's degree or equivalent, plus relevant formal academic or vocational qualification.
• Previous experience that provides the knowledge, skills and abilities to do the job, comparable to 8+ years. In some cases a combination of education, training and directly related experience will be considered sufficient.
• Extensive experience in one or more of these areas: ophthalmology, including general ophthalmology, Diabetic Macular Edema and Geographic Atrophy; rare disease, including Myasthenia Gravis, Huntington's, ALS, DMD, CIDP, DM1 (myotonic dystrophy) and FSHD, with CAR-T experience a plus; or sleep, epilepsy and/or psychiatry, including depression and schizophrenia.
• Good leadership skills, effective mentoring and training, and the ability to motivate and integrate teams.
• Planning and organisational skills for prioritising workload, plus interpersonal and problem solving skills for working in a multicultural matrix organisation.
• Ability to work in a changing environment with complex or ambiguous situations.
• Familiarity with clinical monitoring practices, processes and requirements, good judgment and decision making, and effective oral and written communication in English.
• Ability to evaluate workload against project budget and adjust resources, sound financial acumen and knowledge of budgeting, forecasting and fiscal management, and strong attention to detail.
• A solid understanding of relevant regulations such as ICH/GCP and FDA guidelines, and good computer skills for systems including Outlook, Excel and Word.

Working conditions

Work is performed in an office environment with exposure to electrical office equipment. The role involves frequently driving to site locations and frequent domestic and international travel.

About the company

Thermo Fisher Scientific describes itself as a global team that values passion, innovation and a commitment to scientific excellence, where collaboration and development are part of everyday work. Lifelancer is a talent-hiring platform in life sciences, pharma and IT, connecting talent with opportunities in pharma, biotech, health sciences, healthtech and IT.