Empleos actuales relacionados con Senior Clinical Operations Specialist - Ciudad de México, Ciudad de México - Fortrea

  • Clinical Operations Specialist

    hace 2 semanas

    Ciudad de México, Ciudad de México Worldwide Clinical Trials A tiempo completo

    **About the Role**Worldwide Clinical Trials is seeking a highly organized and detail-oriented Clinical Operations Specialist to join our team. As a Clinical Operations Specialist, you will be responsible for carrying out daily aspects of operational work related to rater selection, rater certification/qualification, rater training content, scale acquisition,...

  • Clinical Operations Specialist

    hace 1 semana

    Ecatepec de Morelos, México Syneos Health Clinical A tiempo completo

    About the RoleWe are seeking a highly skilled Clinical Operations Specialist to join our team at Syneos Health Clinical. As a key member of our Clinical Development team, you will be responsible for performing activities in compliance with applicable Corporate and Clinical Operations Policies, Standard Operating Procedures, and Work Instructions.Key...

  • Clinical Research Specialist

    hace 2 semanas

    Ciudad de México, Ciudad de México Worldwide Clinical Trials A tiempo completo

    About the RoleWe are seeking a skilled Clinical Research Specialist to join our team at Worldwide Clinical Trials. As a Clinical Research Specialist, you will be responsible for all aspects of assigned projects, including clinical assessment, training development, and data review.Key ResponsibilitiesAssist in the review of eCOA/ePRO specifications and engage...

  • Clinical Operations Specialist Focus Regulatory

    hace 2 semanas

    Ecatepec de Morelos, México Syneos Health Clinical A tiempo completo

    **About the Role**Syneos Health Clinical is seeking a Clinical Operations Specialist to focus on regulatory activities for our Mexico Client Based team.As a Clinical Operations Specialist, you will be responsible for performing activities in compliance with applicable Corporate and Clinical Operations Policies, Standard Operating Procedures, and Work...

  • Clinical Operations Specialist

    hace 3 semanas

    Ciudad de México, Ciudad de México SAN Fortrea Chile Limitada A tiempo completo

    Job SummaryFortrea is seeking a highly skilled Clinical Operations Specialist to join our team. As a key member of our clinical operations department, you will be responsible for ensuring the smooth delivery of clinical trials and studies.Key ResponsibilitiesIdentify and appoint new resources to meet ongoing demand.Assign and allocate resources to tasks and...

  • Clinical Data Operations Specialist

    hace 7 días

    Ciudad de México, Ciudad de México Syneos - Clinical And Corporate - Prod A tiempo completo

    Syneos Health Clinical Development Operations Analyst RoleAt Syneos Health, we are committed to accelerating the delivery of therapies that make a difference in patients' lives. As a Clinical Development Operations Analyst, you will play a vital role in our mission by providing essential support to our business units. This position involves creating reports,...

  • Senior Clinical Supplies Specialist

    hace 3 semanas

    Ciudad de México, Ciudad de México Fortrea A tiempo completo

    Job Title: Senior Clinical Supplies SpecialistFortrea is seeking a highly skilled Senior Clinical Supplies Specialist to join our team. As a key member of our Clinical Supplies Services team, you will be responsible for coordinating and overseeing logistics related to clinical and ancillary supplies services.Key Responsibilities:Coordinate and oversee...

  • Operations Associate

    hace 1 semana

    Ciudad de México, Ciudad de México Worldwide Clinical Trials A tiempo completo

    About the RoleThe Operations Associate has primary responsibility for carrying out all daily aspects of the operational work related to rater selection, rater certification/qualification, rater training content, scale acquisition, surveillance maintenance, and workbook/source document for Worldwide Clinical Trials, Inc. (WCT).The Operations Associate works...

  • Clinical Operations Specialist

    hace 6 días

    Ecatepec de Morelos, México Syneos Health Clinical A tiempo completo

    **Transforming Clinical Operations**Syneos Health Clinical is a leading biopharmaceutical solutions organization driven to accelerate customer success. We harness unique clinical, medical affairs, and commercial insights to deliver impactful outcomes in the modern market.At Syneos Health Clinical, we bring the customer and patient to the forefront of...

  • Clinical Operations Director

    hace 7 días

    Ciudad de México, Ciudad de México Bristol-Myers Squibb A tiempo completo

    Job SummaryThis role will be part of the Regional Clinical Operations (RCO), Latam North, R&D regional organization, and will be responsible for the execution of phase I-IV clinical studies in Colombia and Mexico.About the RoleThis leadership position will serve as a member of the RCO LATAM Senior Leadership Team and be part of the RCO and GDO extended...

  • Clinical Trials Specialist

    hace 2 semanas

    Ecatepec de Morelos, México Syneos Health Clinical A tiempo completo

    About the RoleSyneos Health Clinical is seeking a highly skilled Clinical Trials Specialist to join our team. As a Clinical Trials Specialist, you will be responsible for ensuring the smooth conduct of clinical trials, from site qualification to close-out visits. You will work closely with project teams to ensure regulatory compliance and provide guidance to...

  • Senior Specialist

    hace 3 semanas

    Ciudad de México, Ciudad de México Fortrea A tiempo completo

    Clinical & Ancillary Supplies Services Senior SpecialistThe Clinical & Ancillary Supplies Services Senior Specialist plays a crucial role in ensuring the smooth operation of clinical trials. This position requires a strong understanding of logistics and supply chain management, as well as excellent communication and problem-solving skills.Key...

  • Clinical Trials Specialist

    hace 1 mes

    Ciudad de México, Ciudad de México MEX Labcorp Clinical Development, S. de R.L. de C.V. A tiempo completo

    Job OverviewAs a leading global contract research organization (CRO), Fortrea is seeking a highly motivated and detail-oriented Clinical Trials Specialist to join our team. In this role, you will be responsible for coordinating and collecting data and information required by regulatory authorities, including the preparation of study documentation and...

  • Clinical Supplies Specialist

    hace 1 mes

    Ciudad de México, Ciudad de México Thermo Fisher Scientific A tiempo completo

    About the RoleAt Thermo Fisher Scientific, we're committed to enabling our customers to make the world healthier, cleaner, and safer. As a Clinical Supplies Specialist, you'll play a critical role in supporting the day-to-day operations of our study drug, comparators, and ancillaries management.Key ResponsibilitiesCoordinate with vendors to ensure seamless...

  • Senior Regulatory Affairs Specialist with Experience in Clinical Trials

    hace 2 semanas

    Ciudad de México, Ciudad de México 520 ICR Mexico - MEX A tiempo completo

    Job Title: Senior Regulatory Affairs Specialist with Experience in Clinical TrialsJob Summary:We are seeking a Senior Regulatory Affairs Specialist to join our team at 520 ICR Mexico - MEX. As a Senior Regulatory Affairs Specialist, you will play a key role in ensuring regulatory compliance and facilitating the successful execution of clinical trials.Key...

  • Clinical Supplies Specialist

    hace 1 mes

    Ciudad de México, Ciudad de México Thermo Fisher Scientific A tiempo completo

    About the RoleAt Thermo Fisher Scientific, we're committed to enabling our customers to make the world healthier, cleaner, and safer. As a Clinical Supplies Specialist, you'll play a critical role in supporting the day-to-day operations of our study drug, comparators, and ancillaries management.Key ResponsibilitiesCoordinate with vendors and assist with...

  • Clinical Supplies Specialist

    hace 2 meses

    Ciudad de México, Ciudad de México Fortrea A tiempo completo

    {"title": "Clinical Supplies Specialist", "content": "Job SummaryFortrea is seeking a highly skilled Clinical Supplies Specialist to join our team. As a key member of our Clinical Supplies Services team, you will be responsible for coordinating and overseeing logistics related to clinical and ancillary supplies services.Key ResponsibilitiesCoordinate and...

  • Clinical Supplies Specialist

    hace 2 meses

    Ciudad de México, Ciudad de México Thermo Fisher Scientific A tiempo completo

    About the Role:We are seeking a highly skilled Clinical Supplies Specialist to join our team at Thermo Fisher Scientific. As a key member of our operations team, you will play a critical role in ensuring the smooth management of study drugs, comparators, and ancillaries.Key Responsibilities:Support the day-to-day operations of study drug, comparators, and...

  • Clinical Supplies Specialist

    hace 3 semanas

    Ciudad de México, Ciudad de México Thermo Fisher Scientific A tiempo completo

    At Thermo Fisher Scientific, we're committed to enabling our customers to make the world healthier, cleaner, and safer. As a Clinical Supplies Specialist, you'll play a critical role in supporting the day-to-day operations of our study drug, comparators, and ancillaries management. Your responsibilities will include coordinating with vendors, assisting with...

  • Clinical Supplies Specialist

    hace 1 mes

    Ciudad de México, Ciudad de México Thermo Fisher Scientific A tiempo completo

    At Thermo Fisher Scientific, we're committed to enabling our customers to make the world healthier, cleaner, and safer. As a Clinical Supplies Specialist, you'll play a critical role in supporting the day-to-day operations of our study drug, comparators, and ancillaries management. Your responsibilities will include coordinating with vendors, assisting with...

Senior Clinical Operations Specialist

hace 2 meses

Ciudad de México, Ciudad de México Fortrea A tiempo completo
Job Summary

We are seeking an experienced and highly motivated Senior Clinical Operations Specialist to join our team at Fortrea. This role involves managing clinical systems, supporting study documentation, ensuring compliance, and providing leadership and mentorship to junior team members.

Key Responsibilities:
  • Clinical Systems Management:
    • Manage clinical systems, including CTMS milestone updates at Site/Country/Protocol levels.
    • Manage and review study documents and support eTMF management.
    • Manage internal/external communications by publishing and distributing newsletters, memos, and global communication under the guidance of the PM team.
    • Create study plans and templates, including drafting and final formatting of slide decks for meetings, monitoring plans, etc.
  • Data Review:
    • Follow up with CRAs for resolution of outstanding issues/action items related to assigned tasks.
    • Perform Associate Lead/Lead role for assigned projects.
    • Draft and send study-specific reports as per study team instructions.
    • Collaborate with Data Management and Programming teams for reports and communication of data review-related tasks.
    • Initiate standardization of processes across different studies within data review.
    • Perform quality reviews and suggest metrics improvements for data review tasks.
    • Train, coach, and mentor new team members on all data review-related tasks.
    • Perform other data review-related tasks as instructed by the project team and manager.
  • Document Review:
    • Review Initial/Amended Investigator Packages for regulatory compliance before granting green light for site patient enrollment.
    • Review Core/Country/Site Informed Consent Forms for compliance with sponsor and regulatory requirements, and GCP guidelines.
    • Review patient recruiting materials (advertisements) for compliance with sponsor, regulatory requirements, and GCP guidelines.
    • Review Core Protocols for thoroughness, completeness, and GCP compliance.
    • File informed consent forms, patient recruiting materials, and Investigator Package approval documentation in TMF and eTMF.
    • Draft Investigator Package Plans documenting required quality of documents included in Investigator Packages with manager oversight.
    • Provide input for CAPAs related to document review activities.
    • Review CSSP Country and Site Document Review activities to ensure regulatory compliance and adherence to departmental processes.
  • General Responsibilities:
    • Follow all applicable departmental SOPs and Work Instructions.
    • Complete required trainings within specified timelines.
    • Create, review, and revise training materials and plans to support departmental training requirements.
    • Create, review, or revise SOPs or Work Instructions to align with process or tool modifications.
    • Manage day-to-day tasks ensuring quality and productivity.
    • Generate monitoring processes to ensure trainee competence.
    • Manage project and technical documentation appropriately.
    • Provide administrative and technical support to internal departments and teams as needed.
    • Perform checks to ensure the quality of completed work.
    • Execute high-quality, timely monitoring and reporting plans, including specialized monitoring requests for approved protocols.
    • Work on multiple studies and prioritize tasks as needed.
    • Ensure timely escalation and issue resolution.
    • Track and report metrics as determined by management.
    • Identify opportunities and lead the implementation of process enhancements.
    • Support the implementation of tools internally to enhance deliverables.
    • Effectively mentor and train others.
    • Work with global stakeholders.
    • Assist in document management (including document template creation, collection, review, processing, and tracking up to eTMF filing) for all documents within agreed processes/activities or within the scope of GSDM throughout the study duration.
    • Assist in preparing new investigator submission packages for site/regulatory submission.
    • Support study teams for contracts and budget activities for investigative sites, including investigator payment, pass-through payment processing, and tracking.
    • Assist study start-up teams with site start-up activities.
    • Review, support, manage, or assist in managing site clinical trial contracts in accordance with defined processes and timelines.
Qualifications (Minimum Required):
  • Education:
    • University/College Degree in Life Sciences or a related field, or certification in an allied health profession from an accredited institution (e.g., Nursing certification, Medical or Laboratory Technology).
    • Relevant and equivalent experience may be considered in lieu of educational requirements.
  • Experience:
    • 4-5 years of work experience in clinical research.
    • Strong working knowledge of ICH-GCP guidelines and other applicable regulations.
  • Skills:
    • Demonstrated ability to plan, prioritize, organize, and communicate effectively.
    • Attention to detail and high-quality work delivery.
    • Strong interpersonal skills and ability to work collaboratively.
    • Ability to influence and lead others.
    • Ability to facilitate meetings.
    • Experience in leading process improvement initiatives.
    • Ability to mentor and train others.

Fortrea is a leading company in the clinical trials industry, committed to revolutionizing the development process and ensuring the swift delivery of life-changing ideas and therapies to patients in need. As a Senior Clinical Operations Specialist, you will play a pivotal role in the successful execution of clinical trials and contribute to process improvement initiatives.

We are proud to be an Equal Opportunity Employer:

At Fortrea, we strive for diversity and inclusion in the workforce and do not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic.

For more information about how we collect and store your personal data, please see our Privacy Statement.