FSP Bench Sr CTM / Clinical Trial Manager

Santiago ThermoFisher Scientific

Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
Join Us as a Clinical Trial Manager FSP Team - Make an Impact at the Forefront of Innovation
The Clinical Trial Manager FSP 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.

What You'll Do:

- Manage all clinical operational and quality aspects of allocated studies, of low to moderate complexity, in compliance with ICH GCP. In accordance to project specific requirements, may assume Clinical Study Manager (CSM) responsibilities on small and/or less complex projects.
- Develop clinical tools (e.g. Monitoring Plan, Monitoring Guidelines) in conjunction with the Data Quality Plan. Contribute to the development of the Master Action Plan (MAP) for providing clinical related documents. Ensure timely set up, organization, content and quality of the relevant sections of the Trial Master File (local and central). May participate in the design and development of CRFs, CRF guidelines, patient informed consent templates and other protocol specific documents as required. Collaborate with the project manager to prepare, organize, and present at client meetings, including bid defense and hand-off meetings.
- Collaborate with the clinical team and other departments as needed to meet deliverables of the project. Regularly communicate with the team and lead team meetings to ensure that timelines, resources, interactions, and quality are maintained. Responsible for the implementation and training of standardized clinical monitoring processes within the study and according to corporate standard policies. Responsible for the timely archiving of documents and study materials for the department.
- Ensure achievement of the final clinical deliverable within the contractual time period specified by preparing and monitoring clinical activity timelines and metrics, providing status updates to the project manager, regularly reviewing projects using tracking and management tools, implementing recovery actions, reviewing monitoring visit reports, and managing CRF collection and query resolution. Continuously monitor or co-monitors clinical trials to assess performance and ensure contractual obligations are met. In smaller regions, may routinely conduct Accompanied Field Visits (AFVs) and be accountable for project financials.
- May communicate with study sites regarding issues such as protocol, patient participation, case report form completion and other study-related issues.
- May coordinate all start-up activities and ensures that timely ethics committee and regulatory submissions (if appropriate) are addressed. Ensure that essential document quality meets the expectation of Regulatory Compliance Review. Review and follows up on all questions raised by the ethics committees.
- May provide input into preparation of forecast estimates for clinical activities. Responsible for clinical resource management, assignment, delegation of clinical responsibilities and identification of additional resource requirements.

Education & Experience Requirements:

- Bachelor's degree or equivalent and relevant formal academic / vocational qualification
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ 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.

Knowledge, Skills, Abilities:

- Good leadership skills, effective at mentoring and training, and capable of motivating and integrating teams
- Good planning and organizational skills to enable effective prioritization of workload
- Solid interpersonal and problem solving skills to enable working in a multicultural matrix organization
- Capable of working effectively in a changing environment with complex/ambiguous situations
- Familiarity with the practices, processes, and requirements of clinical monitoring
- Good judgment and decision making skills
- Effective oral and written communication skills, including English language proficiency
- Capable of evaluating workload against project budget and adjusting resources accordingly




- Sound financial acument and knowledge of budgeting, forecasting and fiscal management
- Strong attention to detail
- Solid understanding of relevant regulations e.g. ICH/GCP, FDA guidelines, etc.
- Good computer skills to effectively use automated systems and computerized applications such as Outlook, Excel, Word, etc.

Working Conditions and Environment:

- Work is performed in an office environment with exposure to electrical office equipment.
- Frequently drives to site locations and frequently travels both domestic and international.

Why Join Us?

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.

Lo Barnechea, Santiago , Chile
Full time
R30745

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first - developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.

A Day in the Life

Banco de Talento Afirmativo- Personas con discapacidad
ATENCIÓN: Este espacio es exclusivo para PERSONAS CON DISCAPACIDAD. Si esta no es su condición, no proceda con su registro. Hay otras vacantes en nuestra página de carreras que pueden ser de tu interés, ¡échale un vistazo!
Medtronic tiene oportunidades para usted que busca ser parte de un entorno diverso que respeta y alienta a las personas a dar lo mejor de sí mismas todos los días.
Con esta mentalidad, estamos creando este banco de talento para personas con discapacidad para diversas áreas de nuestra empresa. Si estás interesado en formar parte de nuestro equipo, debes aplicar aquí a este banco de talentos para que nuestro equipo de reclutadores pueda analizar tus experiencias de acuerdo a nuestra cultura.
En línea con nuestra misión de aliviar el dolor, restaurar la salud y prolongar la vida, esperamos que puedas ser un socio que nos ayude a transformar la salud en el mundo.

Acerca de Medtronic
Como líder mundial en tecnología, servicios y soluciones médicas, Medtronic mejora la salud y la vida de millones de personas cada año. Creemos que nuestra profunda experiencia en los campos clínico, terapéutico y económico puede ayudar a abordar los complejos desafíos, como el aumento de los costos, el avance de la población y la carga de las enfermedades crónicas, que enfrentan las familias y el sistema de atención médica en la actualidad. Pero no podemos hacerlo solos. Es por eso que estamos comprometidos a crear nuevas asociaciones para desarrollar soluciones efectivas que brinden mejores resultados a los pacientes.

Acerca de la diversidad y la inclusión
En Medtronic, creemos que la diversidad, la equidad y la inclusión impulsan mejores oportunidades de negocio. Esto incluye la creación de una base de talento diversa que difunda la cultura de lo extraordinario y que genere pertenencia a través de un ambiente protegido en la búsqueda de soluciones que restauren la salud, alivie el dolor y prolonguen la vida.

Buscamos talentos de diferentes orígenes, identidad y/o expresión de géneros, edades, razas, orientación sexual, color, nacionalidades, discapacidad, credo y cualquier otra característica, respetando la singularidad de las personas.

Para nosotros, no hay barreras de oportunidades, por lo que utilizamos todos nuestros recursos para llevar igualdad a las comunidades y a nuestra empresa. Queremos un futuro que involucre a todos nuestros empleados para que puedan contribuir con sus experiencias y hacer que nuestro trabajo difunda mejoras de salud para todas las comunidades del mundo.

Descripción:
Buscamos profesionales motivados e interesados en desarrollarse en nuestras áreas de especialización_
Logística; EHS&S; Finanzas; Recursos humanos; Marketing y Ventas; Administración; Tecnología de la información; Compras; Legal; Servicio al cliente; Instalaciones, entre otros.
Tenga en cuenta que esta solicitud se considerará para puestos futuros. Si quieres optar a un puesto vacante para este momento, accede adicional
La vía de contratación para esta vacante seguirá el proceso de forma estándar, sin cambios en sus etapas.




Postular a nuestro banco de talentos no garantiza la contratación, ya que dependerá de la disponibilidad de vacantes y evaluación de hojas de vida y requisitos para cada una de las oportunidades.
Nuestro equipo de Atracción y Selección siempre está analizando currículos y atento a cualquier oportunidad, si hay un puesto que esté dentro de tu perfil, nos pondremos en contacto contigo para participar en nuestro proceso de selección.
Ley de Protección de Datos Personales
En cumplimiento de los requisitos de la Ley de Protección de Datos Personales, Medtronic informa que utilizará sus datos personales recopilados con el fin de permitir su participación en nuestro proceso de selección. Para obtener más detalles sobre cómo procesamos los datos personales, consulte nuestra Política de privacidad.

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

Benefits & Compensation

**Medtronic offers a competitive Salary and flexible Benefits Package**
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D; lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
**We change lives** . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That's who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives.
**We build extraordinary solutions as one team** . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.
**This life-changing career is yours to engineer** . By bringing your ambitious ideas, unique perspective and contributions, you will.

- Build a better future, amplifying your impact on the causes that matter to you and the world
- Grow a career reflective of your passion and abilities
- Connect to a dynamic and inclusive culture that welcomes the challenge of life-long learning

These commitments set our team apart from the rest:

Experiences that put people first . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.

Life-transforming technologies . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms.

Better outcomes for our world . Here, it's about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls.

Insight-driven care . Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here ( .

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