Thermo Fisher / PPD
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.
Our global Clinical Operations colleagues within our 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.
The FSP Solution:
PPD's Functional Service Provider division partner with and serve as an extension of our PPD team, supporting our customers key functions. We cover customer needs on every level, allowing them to do more with less, with an uncompromising commitment to quality. We deploy the same top-tier talent in ALL engagement models. Exceptionally trained, rigorously supported and technologically empowered to help customers manage capacity and set programs up for success.
Joining within our PPD FSP functional area, allows you to join the renowned PPD CRO and still gain invaluable client dedicated experience.
Discover Impactful Work:
To lead local study teams at country level to deliver committed components of clinical studies according to agreed resources, budget and timelines complying with international guidelines such as ICH-GCP as well as relevant local regulations. In addition may perform site monitoring as needed to support the flexible capacity model. The position is responsible to ensure that sites are identified, site qualifications performed, set up, initiated, monitored, closed and documentation archived.
A Day in the Life:
• Has the overall responsibility for the study commitments within the country and for timely delivery of data to required quality.
• Leads Local Study Team consisting of CRA(s), CSA(s), for assigned study/studies
• Leads and optimises the performance of the Local Study Team(s) at country level ensuring compliance with Procedural Documents, ICH-GCP and local regulations.
• Ensures, as required, that clinical and operational feasibility assessment of potential studies is performed to the highest quality.
• Coordinates the site selection process by identifying potential sites/investigators, performing initial Site Quality Risk Assessment, and conducting Site Qualification Visits to evaluate suitability and quality risks.
• Ensures timely submission of application/documents to EC/IRB at start up and for the duration of the study. Works together with Regulatory Affairs to ensure timely delivery of application/documents for submissions to Regulatory Authority for the duration of the study, and in line with local regulations.
• Ensures timely preparation of country financial Study Management Agreement (fSMA) and maintains accurate study budget in clinical studies financial system by regular checks of the system and financial reports (as agreed with Director, SMM/ Director, Country Head.
• Ensures timely preparation of local Master CSA (including site budget) and amendments as needed.
• Ensures timely preparation of country level Master Informed Consent Form (MICF) and subsequent site level ICFs, as required, including any relevant translations, and in line with relevant SOPs and local regulations.
• Ensures all country and site level trial essential documents required by ICH-GCP prior to study start have been collected and verified for correctness, prior to setting sites ready to enrol, and in line with SOPs.
• Plans and coordinates applicable local drug activities (from local purchase or reimbursement to drug destruction).
• Sets up and maintains the study in CTMS at study country level as well as local websites as required by local laws and regulations.
• Oversees, manages and coordinates monitoring activities from site activation through to study closure at country and site level in accordance with the Monitoring Plans.
• Reviews monitoring visit reports (as required and following SOPs and pro-actively advices the monitor(s) on study related matters.
• Performs any required co-monitoring, Accompanied Site Visits/training visits with study CRAs.
• Proactively identifies risks and facilitates resolution of complex study problems and issues.
• Organises regular Local Study Team meetings on an agenda driven basis.
• Actively works towards achieving good personal relationships with all Local Study Team members, sites’ staff and global stakeholders.
• Reports study progress/update to the Global Study Associate Director/ Global Study Team including SMM Lead.
• Contributes to patient recruitment strategy including regular communication with participating Investigators as necessary.
• Develops, maintains and reviews risk management plan on country study level: proactively manages sites, stakeholders, local and global vendors and customers to ensure risks are timely identified, mitigated and managed.
• Communicates and co-ordinates regularly with National Co-ordinating Investigator / National Lead Investigator on recruitment and other study matters, if applicable.
Keys to Success:
Education
Experience
Previous experience as CTM that provides the knowledge, skills, and abilities to perform the job (comparable to 3+ years).
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Experience in site monitoring
Knowledge, Skills, Abilities
Demonstrates flexibility and resilience with the ability to evolve in an always changing and challenging (internal and external) environment, processes, and systems.
Demonstrates excellent leadership skills, promoting motivation and high-quality performance of others to accomplish individual, team, and organizational objectives.
Demonstrates an excellent understanding of clinical study, drug development, sample management, and other associated processes and quality requirements.
Has a strong project management approach and demonstrated ability to work and lead in a matrix team environment involving both internal and external partners.
Proficient in acting as the organization's spokesperson to external physician investigators and other external clinical site staff, institutional review boards, etc., including responding to intricate questions.
Capable of performing well within the local setting and, if needed, in additional regional settings while encouraging positive relationships with remote central team members. Ability to work effectively in a remote environment.
Capable of establishing and coordinating priorities and performance objectives in a nearby setting and, when necessary, in additional regional settings.
Effectively plans, communicates, coordinates, and facilitates delivery of local/regional team objectives.
Demonstrates a solid understanding of country local regulations and, if required, basic understanding of other countries' regulations, ICH-GCP guidelines, and written standards.
Available and willing to travel for project-related activities as required (e.g., Investigator & Monitors Meeting attendance).
Acts as a role model in line with the organization's culture, including values and behaviours.
Able to understand and apply new digital innovations to clinical trials.
Able to demonstrate conceptual, analytical, and strategic thinking including data literacy.
Effective at problem-solving and conflict resolution.
Demonstrates good English language written and verbal communication skills in addition to proven negotiation skills.
Demonstrates flexibility with high learning agility.
Demonstrates strong computer skills and the ability and willingness to learn and master new or evolving computer systems to support business requirements effectively.
Working Environment
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.
Ability 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 require travel.
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
Apply today! http://jobs.thermofisher.com
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.
Accessibility/Disability Access
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