Clinical Team Lead

hace 1 semana

Buenos Aires, Buenos Aires C.F., Argentina Avature A tiempo completo

Trial Preparation, Conduct and Closeout:

  1. Selects sites, conducts and delivers the trial according to the clinical trial protocol, within trial timelines, and in compliance with ICH-GCP, procedures and all other relevant applicable regulations.
  2. Perform/supervise local adaptation of the required documents for submission according to the package provided by the trial team in compliance with ICH-GCP, procedures and all other relevant applicable regulations.
  3. Ensure all Regulatory Requirements are satisfied prior to trial/site initiation.
  4. Update all required dashboards set-up for the trial oversight.
  5. Oversee recruitment and define strategic approach at local level.
  6. Set up, manage and review OPU trial budget to ensure appropriate level of financial oversight. Timely budget updates based on trial changes.
  7. Ensure appropriate trial-specific training of team members in line with Trial Training Plan.
  8. In collaboration with Site Monitoring Lead and CRAs:
    1. Conduct appropriate trial oversight for the trials by monitoring compliance of trial sites and BI team to GCP, local regulations, BI SOPs (for BI staff and issue), and adherence to trial protocol.
    2. Ensure adequate trial supply distribution to sites.
    3. Oversee continuous and timely data entry and cleaning, and on time Data Base Lock.
  9. Trial contact for CRAs, investigators and site staff. Conduct regular project meetings during the trial, prepare and distribute associated minutes.
  10. In collaboration with Trial Record Specialist and with supports from CRAs as appropriate, ensures collection of required documents, with timely, complete and compliant archiving of all relevant documents for the eTMF and CTR Appendices.
  11. Supervision of close-out activities in compliance with ICH-GCP, procedures and all other relevant applicable regulations.

The Services will take place mainly in homebased with a sustained presence on our Reims site the first weeks for training / Coaching / Handovers. Subsequently, one day per week on site may be requested (to be redefined with the BI referent).

Management and Relationship Responsibilities:

Develop and maintain company relationships with external experts and investigational sites by coordinating and ensuring cross-functional collaboration amongst Clinical Operations and Medical Affairs on local level and supporting CRAs in site contacts. Collaborates with other BI functions to support Trial Management topics and support integration across Medicine. May participate in working groups related to Trial Management, represent trial on local level, providing updates on trial within OPU.

Regulatory and/or Organizational Requirements:

Ensures all tasks are carried out in accordance with respective applicable BI SOPs, BI Business Practices and regulatory requirements. Ensures that all interactions and engagements are carried out with the highest ethical and professional standards and that all work is accomplished with quality and in accordance with BI Values.

Requirements:

  1. At least 5 years of experience in Clinical Research working for a pharmaceutical company or CRO.
  2. Strong clinical trial project management experience or CRA lead with potential to develop.
  3. Regional LATAM experience is preferred.
  4. Previous CRA experience is desirable.
  5. Understanding of local/regional major regulations.
  6. University degree in Life Science.
  7. Experience in managing oncology trials is desirable.
  8. Fluent in English is a must.

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

Did you know? Fortrea is looking for problem-solvers and creative thinkers who are passionate about breaking down barriers faced by sponsors of clinical trials, and who are committed to helping transform the development process to get promising life-changing ideas and therapies to patients faster. Join us as we cultivate a workspace where all employees have the opportunity to grow and make impacts on a global scale.

For more information and questions related to Fortrea, please visit Fortrea is proud to be an Equal Opportunity Employer: As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does 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.

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