Clinical Team Lead

hace 7 meses

Buenos Aires, Argentina Labcorp 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 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:

- 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.
- Ensure adequate trial supply distribution to sites.
- 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**:

- At least 5 years of experience in Clinical Research working for a pharmaceutical company or CRO.
- Strong clinical trial project management experience or CRA lead with potential to develop.
- Regional LATAM experience is preferred
- Previous CRA experience is desirable
- Understanding of local/regional major regulations
- University degree in Life Science
- Experience in managing oncology trials is desirable
- 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?**

**Labcorp is proud to be an Equal Opportunity Employer**:
As an EOE/AA employer, Labcorp 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, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

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

  • Clinical Lead

    hace 7 meses

    Buenos Aires, Argentina Novasyte A tiempo completo

    Calling ALL experienced Clinical Leads. The Clinical Lead provides leadership of the clinical team, in support of the project leader, and in collaboration with the other functional teams, to achieve the delivery of the project’s overall objectives to the Sponsor’s satisfaction per contract while optimizing speed, quality and cost of delivery and in...

  • Clinical/sr. Clinical Lead

    hace 7 meses

    Buenos Aires, Argentina Novasyte A tiempo completo

    Calling ALL experienced Clinical Leads. The Clinical Lead provides leadership of the clinical team, in support of the project leader, and in collaboration with the other functional teams, to achieve the delivery of the project’s overall objectives to the Sponsor’s satisfaction per contract while optimizing speed, quality and cost of delivery and in...

  • Senior/clinical Data Team Lead, Iqvia Biotech

    hace 7 meses

    Buenos Aires, Argentina Novasyte A tiempo completo

    Join our team as a Senior Data Team Lead, IQVIA Biotech! - Senior Data Team Lead position is to manage all data management (DM) tasks to include more complex and/or larger studies and/or a program of studies from start-up through database closure and archival producing high-quality databases for analysis and potential regulatory submissions.- Essential...

  • Clinical Team Manager

    hace 7 meses

    Buenos Aires, Argentina Thermo Fisher Scientific A tiempo completo

    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...

  • Associate Clinical Lead Director

    hace 7 meses

    Buenos Aires, Argentina Novasyte A tiempo completo

    Calling All experience AD Clinical Leads. The Associate Clinical Lead Director is responsible for clinical delivery of full service, large, multi-regional studies or a program of studies to meet contractual requirements in accordance with (Standard Operating Procedures) SOPs, policies and practices. Tasks & Responsibilities: - Ensure clinical delivery of...

  • Clinical Scientist, Cronos

    hace 2 meses

    Buenos Aires, Argentina IQVIA A tiempo completo

    Job Overview Associate Clinical Leads are an integral part of clinical trial delivery, working alongside clinical teams to improve patients’ lives by bringing new drugs to the market faster. The Associate Clinical Lead is a member of the core project team responsible for clinical delivery of clinical studies to meet contractual requirements in accordance...

  • Clinical Science

    hace 7 meses

    Buenos Aires, Argentina Novartis A tiempo completo

    395161BR **Clinical Science & MIC Lead**: Argentina **About the role** **Work Model**:Hybrid **Locality**:Buenos Aires **About the Role**: Work with the Evidence Generation Lead to be a partner to the therapeutic areas (TA) in the development of relevant and impactful local scientific and medical evidence. Enable the design and execution of...

  • Lead Clinical Data Manager

    hace 1 mes

    Buenos Aires, Argentina Parexel A tiempo completo

    Parexel FSP is looking for a Lead Clinical Data Manager with Early Development experience to join the Argentina team. **Description of Role & Responsibilities** Under the direction of the applicable management, the Lead Clinical Data Manager (LCDM) is responsible for executing end-to-end data management activities pertaining to clinical trials, including...

  • Manager, Clinical Operations

    hace 9 meses

    Buenos Aires, Argentina Novasyte A tiempo completo

    Unleash Your Potential It takes curiosity and intellectual courage to accomplish great things. It takes brave minds to bring powerful ideas to reality and transform healthcare. We are a diverse, global team that shares a passion for collaboration and solving complex problems. Together, we help customers drive healthcare forward. Join IQVIA and see where...

  • Clinical Specialist Cathlab

    hace 4 meses

    Buenos Aires, Argentina Medtronic A tiempo completo

    At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life You will be responsible for coronary, renal denervation, aortic, peripheral and intravenous...

  • Clinical Trial Liaison Director

    hace 2 semanas

    Buenos Aires, Argentina Syneos Health Commercial Solutions A tiempo completo

    **Description** **There’s one thing you do that’s exceptional: lead.** You formulate a plan and empower your team to provide clinical expertise to health care providers helping them to improve patient outcomes. Your capacity to creatively strategize, motivate clinicians, and elicit achievement makes you the right fit for a Field Director role with...

  • Manager, Clinical Operations

    hace 6 meses

    Buenos Aires, Argentina Icon plc A tiempo completo

    Requirements: - Located in Argentina- Bachelor’s degree- Advanced English Level- Minimum 6 years Clinical Research experience that includes a minimum 4 years relevant experience as a Senior CRA or Principal CRA (in a Lead CRA role), or at least 2 years as a CRA Manager or equivalent job role.- Knowledge of ICH-GCP guidelines and ability to review and...

  • Clinical Operations Manager

    hace 7 meses

    Buenos Aires, Argentina ICON plc A tiempo completo

    **Requirements**: - Located in Argentina - Bachelor’s degree - Advanced English Level - Minimum 6 years Clinical Research experience that includes a minimum 4 years relevant experience as a Senior CRA or Principal CRA (in a Lead CRA role), or at least 2 years as a CRA Manager or equivalent job role. - Knowledge of ICH-GCP guidelines and ability to review...

  • Team Lead, Translation Project Management

    hace 7 meses

    Buenos Aires, Argentina Novasyte A tiempo completo

    Working with the wider Project Management team, the Team Lead is responsible for leading a team of Senior Project Managers, Project Managers and Junior Project Managers and for ensuring translation and localization projects are delivered according to IQVIA’s standards and client requirements. - Day-to-day line management and mentoring of a team of Junior...

  • Business Operations Lead

    hace 6 meses

    Buenos Aires, Argentina IQVIA A tiempo completo

    "The Business Operations Lead is a supporting role within Business Operations. This role will support a variety of tasks that fall within Business Operations remit. They are responsible for collaborating with the clinical trials payments organization to identify, recommend, and deliver resolutions to process and performance changes within the organization....

  • Business Operations Lead

    hace 6 meses

    Buenos Aires, Argentina Novasyte A tiempo completo

    "The Business Operations Lead is a supporting role within Business Operations. This role will support a variety of tasks that fall within Business Operations remit. They are responsible for collaborating with the clinical trials payments organization to identify, recommend, and deliver resolutions to process and performance changes within the organization....

  • Clinical Trial Liaison Director

    hace 7 días

    Buenos Aires, Argentina Syneos Health A tiempo completo

    There’s one thing you do that’s exceptional: lead. You formulate a plan and empower your team to provide clinical expertise to health care providers helping them to improve patient outcomes. Your capacity to creatively strategize, motivate clinicians, and elicit achievement makes you the right fit for a Field Director role with Syneos...

  • Clinical Specialist Cathlab

    hace 2 semanas

    Buenos Aires, Argentina Medtronic A tiempo completo

    At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. **A Day in the Life**:We’re a mission-driven leader in medical technology and solutions with a legacy of...

  • Clinical Specialist Cathlab

    hace 4 horas

    Buenos Aires, Argentina Medtronic A tiempo completo

    At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life We’re a mission-driven leader in medical technology and solutions with a legacy of integrity...

  • Clinical Trial Manager

    hace 2 meses

    Buenos Aires, Argentina ICON Plc A tiempo completo

    Senior Clinical Trial Manager - Argentina, Buenos Aires ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking a Senior...