Clinical Team Manager/Sr. (CTM) - FSP

Thermo Fisher Scientific•Wilmington, NC

1d•Onsite

About The Position

The Clinical Trial Manager is 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. The Clinical Trial Manager interprets data on project issues and makes good business decisions with support from experienced team members or line manager. 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. The position involves working on projects of low to moderate complexity and as part of a team of CTMs. Summary Take responsibility for coordinating the clinical monitoring activities, overseeing the CRO clinical /site management activities and co-monitoring the assigned Phase I clinical studies in accordance with regulatory requirements, Good Clinical Practice (GCP) guidelines and SOPs to the most rigorous standards of quality, timely delivery and within budget, in order to assist in the delivery of Clinical Development objectives and achieve clinical excellence. Coordinate the achievement of assigned clinical study deliverables within a matrix organization under the leadership of the Clinical Project Managers (CPM). Be a client representative at site and build relationship with our investigators.

Requirements

Life science or medical graduate or other relevant qualifications.
Minimum: CRA graduated
Relevant experience of pharmaceutical drug development: Experience of minimum 1 year (ideally 2 years) of Lead CRA e.g. coordination of clinical activities/site management activities for the set up and running of international registrational studies (multiple sites/countries).
Experience as a Field CRA monitor for at least 3 years (CROs or Pharma Industry)
Experience in Phase I Oncology
Excellent Knowledge of Good Clinical Practice (GCP), ICH regulations.
Experience in preparing clinical study documentation for study set up, maintenance and closing
Experience in managing and developing relationships with Contract Research Organizations (CROs).
Global studies (multiple countries/sites) experience
Previous experience in the Therapeutic area of studies (Neuroscience, Oncology or radiopharmaceutical compound, etc.) is a plus
English: Strong intermediate level
Ability to work in a strong regulated environment within a quality management system (QMS)
Advanced knowledge of softward (eg Word, Excel, PowerPoint, Adobe Reader)
Ability to organize and prioritize
Able to produce work in teams and within a multi-disciplinary environment
Basic Financial Knowledge- must be able to work with financial tracking tools
Knowledge of Pharmaceutical Industry R&D
Excellent knowledge of Good Practices, ICH regulations and any others as appropriate and other clinical study regulations
Continuous drive to improve one’s knowledge and performance (in terms of quality, timeliness and costs)
Strong organizational, coordinating & coaching plus interpersonal skills
Excellent verbal and written communication skills
Show professional awareness and integrity
Demonstrate a pragmatic/hands-on approach
Ability to work within a team and multidisciplinary & matrix environment, support others
Proactive approach
Flexibility

Nice To Haves

Previous experience in the Therapeutic area of studies (Neuroscience, Oncology or radiopharmaceutical compound, etc.) is a plus

Responsibilities

Ensure clinical activities coordination & oversight
Ensure efficient and thorough study start-up by overseeing the Clinical team of the CROs and working closely with other relevant team members involved in the study set-up (DM, reg, CMC, etc); ensure feasibility report are exhaustive, Review site feasibility reports as per oversight plan , support the CPM in site selection, verify timely collection of essential study documents, such as regulatory and ethics committee documents for submission, and by controlling that all set up activities are performed prior to each site initiation, as per the oversight plan.
Support and ensure that all specific Client/CRO EDC system tasks under the clinical responsibility are completed and achieved according to the defined timelines without jeopardizing the start of a trial.
Support the Clinical CRO in the training of the CRAs on all study specific operational activities and participate in the organization and preparation of the monitor and investigator meetings in collaboration with the other study team members (Corporate and/or affiliates, CROs as appropriate)
Assist the CPM/ study team in the evaluation of detailed timelines and establishment of clinical studies milestones for assigned projects, ensuring that they are performed to the most rigorous standards of quality and timely delivery.
Prepare and/or assist in the production of all documents necessary to oversee the clinical activity implementation, monitoring and reporting in a professional, high quality and timely manner (such as monitoring oversight plan and clin Customize site Key Risk/Performance Indicator template and follow these KRIs/KPIs at frequency agreed in the oversight plan
Validate the final clinical study documents (such as study manual, monitoring plan, prepared by the Clinical CRO.
Review all/a sample of site visit reports as per the Oversight Monitoring Plan, ensuring timely and appropriate follow up of issues raised by monitors (Corporate & affiliates and/or CROs as appropriate).
If applicable, provide support and guidance to Internal CRAs (Client Corporate & Affiliates with provision of some supervision in specific cases).
Coordinate and manage the CRO relationship, assisting CRO CRAs/CTLs when and where necessary.
Collaboration with the CPM in the RFP process and participation to BID defense meeting
If applicable to set up regular meeting with MSL (Medical Science Liaison) at LMA (Local Medical Affairs) who can support Clinical Operations at various steps (site qualification, site recruit
Contribute to the efficient operation of the TA Group and to transversal project cross- TAs and other departments within client (e.g. systems implementation, change management initiatives, continuous improvement initiatives
Ensure the monitoring oversight of different activities entrusted
Co-monitor clinical studies according to the oversight plan, ensuring adequate contact with investigator sites, identifying and solving issues in study progress, verifying data in-house or by conducting co- monitoring visits, in collaboration with other study team members, and following up as required with CROs/CRAs/investigator.
Participate in the ongoing clinical study data reviews in collaboration with the other study team members.
Make appropriate and timely reporting in CTMS, with regular checks for quality and accuracy.
Ensure the agreed timelines for data collection (CRF/eCRF) and data clarifications/queries are met, sending information to data-management and monitoring CROs as appropriate.
Ensure that study samples/assessments flow as required per protocol is well coordinated between the various stakeholders (CROs/Vendors/client departments) from site to the central facility/specialized lab.
Participate in TMF quality check review regularly to ensure adequate completion during the study course with a final thorough review at the end of the trial prior to study archiving
Participate in the preparation and follow-up of any other study systems (such as IWRS/IMP forecasting/flow etc, as required
Maintain and review key clinical documents required for Clinical Study Report (CSR), to ensure adequate quality (e.g. for CSR appendices publishing)
As appropriate, participate in the preparation of study documents and perform site visits prior to audits /inspection and assist in audit follow-up /findings resolution.
Be a client ambassador at site and create relationship with our Investigators
Perform various study related functions to ensure the execution of clinical studies such as act as site CRA as directed by line manager act as back up of the CPM when requested
Complete all of the above activities within the framework and in compliance with client Global SOPs and other documentation in force within the client group.
Clinical activities (out of studies) Contribute/participate on SOP update review training material created by Process Management
Contribute to the efficient operation of the TA Group and to transversal project cross- TAs and other departments within client (e.g. systems implementation, change management initiatives, continuous improvement initiatives
EHS Responsibilities Comply with applicable EHS regulations and procedures. Participate in the site's EHS performance by reporting risks, malfunctions or improvements Participate in mandatory EHS training

Benefits

When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference.
As the world leader in serving science, our colleagues develop critical solutions through innovation—and build rewarding careers.
Discover their extraordinary stories and connection to our Mission to enable our customers to make the world healthier, cleaner and safer.
Their work is a story of purpose.
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion.
Our Mission is to enable our customers to make the world healthier, cleaner and safer.
Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them.
Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.
Please contact us to request accommodation.
Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.