Sr. or Clinical Trial Manager, Oncology; Remote-Brazil, Biotech

1 semana atrás


Brasília, Distrito Federal, Brasil IQVIA Tempo inteiro
IQVIA Biotech is committed and dedicated to the small biotech & biopharma companies we support. Opportunities available for an experienced Clinical Trial Manager II or Senior Clinical Trial Manager. Previous clinical trial management and CRO experience preferred.

Therapeutic requirements/preference:
any of the following Oncology/Hematology/CAR T/Cell & Gene Therapy. Contact me at for additional information. We are seeking candidates with a minimum of the following requirements

BS/BA (or equivalent) in one of the life sciences plus a minimum of 4 years direct experience in clinical studies
At least 2 years' experience as a Clinical Monitor/CRA, as well as experience in data handling or analysis.
Prior experience as a Clinical Research Associate. (strongly preferred)

OurTrial Managers are responsible for all activities related to implementation and execution of clinical studies and the delivery of study metrics/deliverables.


ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:
Responsible for all activities related to implementation and execution of clinical studies that include: Client Duties/Responsibilities:

Work with Project Manager (PM) to define program targets for clinical monitoring staff and assure work is documented within contracted project scope.

Communicate and document all interactions with client as required by SOP.
Serve as client advocate within IQVIA Biotech.
Develop and implement Clinical Monitoring Plan.

Team Duties/Responsibilities:
Responsible for assuring needs of clinical sites are met by facilitating clinical monitoring processes, including: Coordinate site management activities:

Site identification, recruitment, and selection.
Regulatory document collection and review.
Overall scheduling and management of all site visits.
Develop site/monitoring tools and training materials.

Review and identify trends in enrollment and data entry at sites and proactively interface with clinical monitoring team and client to identify solutions.


Coordinate and oversee daily operations of clinical monitoring team:

Set and enforce project timelines with the assigned study team.
Coordinate remote review of clinical data within EDC system.
Oversee monitoring visit schedule to ensure compliance with frequency set forth in contract.
Review and approve trip reports and follow-up letters within required timeframe.
Schedule and manage weekly CRA project team meetings.
Ensure CRAs assigned to team receive therapeutic and project-specific training.
Manage quality and regulatory compliance among clinical monitoring team and investigational sites.

Manage project milestones and proactively address deficiencies:

Attend and provide information at monthly projections meetings.
Attend and provide information at weekly client teleconferences/team meetings.

Assist Project Manager in identifying Out of Scope activities and assuring that such activities do not begin until the client provides authorization.


Manage CRA performance:
Define and implement functional standards, goals, and expectations with clinical monitoring team.
Serve as CRA mentor and perform accompanied field assessment visits as required.

Participate in the performance appraisal program by providing timely and accurate feedback regarding the performance of each respective CRA.


Documentation Duties/Responsibilities:
Assure that the appropriate IQVIA Biotech and/or sponsor SOPs are followed.
Ensure all project documentation is appropriately filed per IQVIA Biotech SOPs.
Assist PM in preparation of audit responses, as appropriate.
Assist PM with preparation of information for inclusion in monthly report to client.

Budget/Contract Duties/Responsibilities:
Assist PM in review of project budgets, monitoring costs, potential overruns and propose/implement cost effective solutions.
Define the scope of work with the client and clinical monitoring team.
Assist PM in identifying and generating changes in scope and notify client of potential changes in scope.
Review and approve CRA travel expenses and time sheets.

KNOWLEDGE, SKILLS &

ABILITIES:
Thorough knowledge of clinical research process.
Prior experience as a Clinical Research Associate.
Strong communication skills (verbal and written) to express complex ideas.
Excellent organizational and interpersonal skills.
Positive attitude and ability to interact with all levels of staff to coordinate and execute study activities.
Ability to manage multiple priorities within various clinical trials.
Ability to reason independently and recommend specific solutions in clinical settings.
Understanding of basic data processing functions, including electronic data capture.
Working knowledge of current ICH GCP guidelines and applicable regulations.
Able to mentor CRAs and more junior Clinical Trial Managers.
Able to qualify for a major credit card.
Valid driver's license; ability to rent automobile.
Willingness and ability to travel domestically and internationally, as required.

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry.

We believe in pushing the boundaries of human science and data science to make the biggest impact possible - to help our customers create a healthier world.

Learn more at

  • Brasília, Distrito Federal, Brasil IQVIA Tempo inteiro

    Clinical Trial Manager - Sponsor Dedicated. Clinical Trial Manager provides for the regional/global coordination of clinical trial management activities for internally managed and/or outsourced trials. These services lead the Study Management Team (SMT) and ensure regional/global clinical operations deliverables progress according to agree upon timelines and...


  • Brasília, Distrito Federal, Brasil Gilead Sciences, Inc. Tempo inteiro

    Director, Clinical Development Oncology – LATAM region Director, Clinical Development Oncology – LATAM region Brazil - Sao Paulo Clinical Development & Clinical Operations Regular Job DescriptionAt Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer –...

  • Clinical Trials Assistant 1

    2 semanas atrás


    Brasília, Distrito Federal, Brasil IQVIA Tempo inteiro

    Job Overview Perform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery. Essential Functions Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical...

  • Clinical Trial Associate

    1 semana atrás


    Brasília, Distrito Federal, Brasil ICON Tempo inteiro

    ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development...


  • Brasília, Distrito Federal, Brasil IQVIA Tempo inteiro

    Are you looking for an opportunity in Clinical Research? Do you want to work for an industry leading company that offers you experience and supports career progression whilst giving you the option of working flexibly? If so, come and join us - IQVIA are looking Clinical Research Coordinator. This role has an immediate start working 40 hours a week for a...

  • Medical Director

    1 semana atrás


    Brasília, Distrito Federal, Brasil Allucent Tempo inteiro

    At Allucent, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.We are looking for a Medical Director to join our A-team (hybrid*/remote). As a Medical Director at Allucent, you are responsible for working...


  • Brasília, Distrito Federal, Brasil IQVIA Tempo inteiro

    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 your...


  • Brasília, Distrito Federal, Brasil Marken Ltd. Tempo inteiro

    Title: Sr. Business Development Manager (Brazil)Job Purpose:The Sr. Business Development Manager for Marken is responsible for building up their defined territory and/or defined accounts by supporting and growing existing and new client relationships within the Logistics, Clinical Supply and/or Pharmaceutical industries.This person defines organizational...


  • Brasília, Distrito Federal, Brasil BOSTON SCIENTIFIC Tempo inteiro

    Additional Location(s): N/A Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest...


  • Brasília, Distrito Federal, Brasil Iqvia Tempo inteiro

    Essential Functions Provide support for clinical research to investigators and site staff, including: Verify and correct research study information on source documents, research queries, and variances; provide feedback to the site data collector. Input research study data into trial Electronic Data Capture (EDC) system, ensuring quality control for content,...


  • Brasília, Distrito Federal, Brasil IQVIA Tempo inteiro

    All resumes must be in English. Provide support and assistance to project managers and project teams related to the assigned project(s). Will support all project-related activities for assigned projects in accordance with SOPs, policies and practices. Essential Functions Assist with the establishment of new procedures and offer suggestions for process...


  • Brasília, Distrito Federal, Brasil IQVIA Tempo inteiro

    As a Site Activation Coordinator, you'll perform tasks at a country level (for the North American team) associated with site activation activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities....

  • General Manager Brazil

    2 semanas atrás


    Brasília, Distrito Federal, Brasil UNIS Group Tempo inteiro

    Are you ready to drive strategic growth and lead a dynamic team to new heights of success? Do you excel at transforming challenges into opportunities and inspiring a team to achieve exceptional results?, If leadership is in your DNA and you are determined to make a significant impact on a global scale, your next career milestone is within reach As the...

  • General Manager Brazil

    2 semanas atrás


    Brasília, Distrito Federal, Brasil UNIS Group Tempo inteiro

    Are you ready to drive strategic growth and lead a dynamic team to new heights of success? Do you excel at transforming challenges into opportunities and inspiring a team to achieve exceptional results?, If leadership is in your DNA and you are determined to make a significant impact on a global scale, your next career milestone is within reachAs the General...


  • Brasília, Distrito Federal, Brasil IQVIA Tempo inteiro

    Role & ResponsibilitiesJoin our team as a Manager to support COA Management activities at IQVIA Patient Centered Solutions group.Manage the licensing and electronic implementation processes of Clinical Outcome Assessments (COAs) for Clinical Trials.Act as the primary contact with external vendors and internal departments.Track the performance of COAs...


  • Brasília, Distrito Federal, Brasil Apple Tempo inteiro

    The people here at Apple don't just build products — they create the kind of wonder that's revolutionized entire industries. It's the diversity of those people and their ideas that encourages the innovation that runs through everything we do, from amazing technology to industry-leading environmental efforts. We are seeking a hardworking and results-focused...


  • Brasília, Distrito Federal, Brasil New Sun Crop Science Tempo inteiro

    E-mail Entre para salvar National Sales Manager needed in Brazil na New Sun Crop Science . Chengdu New Sun Crop Science is a leading bio-pesticides and bio-stimulant company headquartered in China. With a focus on sustainable agricultural solutions, we specialize in the development and production of biological pesticides and stimulants. As part of our...

  • Contract Negotiator

    1 semana atrás


    Brasília, Distrito Federal, Brasil IQVIA Tempo inteiro

    Job Overview Develop the global contracting strategy and support the delivery of all required start-up contracting activities for selected sponsors, studies or multi-protocol programs as determined by the Sponsor's requirements. Essential Functions Develop Coordinate the development of investigator grants and estimates, contracting strategies and proposal...


  • Brasília, Distrito Federal, Brasil Insight Global Tempo inteiro

    Title: Sr. Technical Program Manager (AI/ML)Duration:12 month contract (likelihood for conversions/extensions)Location: Remote in LATAMMust HavesBachelor's degree in computer science, engineering, or related field8+ Years of experience as TPM – leading cross functional teamsStrong Experience with program management3-4 years of experience with data science...


  • Brasília, Distrito Federal, Brasil Insight Global Tempo inteiro

    Title : Sr. Technical Program Manager (AI/ML)Duration: 12 month contract (likelihood for conversions/extensions)Location : Remote in LATAMMust HavesBachelor's degree in computer science, engineering, or related field8+ Years of experience as TPM – leading cross functional teamsStrong Experience with program management3-4 years of experience with data...