Contract Clinical Trial Analyst
7 meses atrás
Diversity, Equity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for more than 130 years. Regardless of your race, belief, sexual orientation, religion, or any other trait, YOU are welcome in all open positions at the largest healthcare company in the world.
When You Join Johnson & Johnson, Your Move Could Mean Our Next Breakthrough.
We are searching for the best talent for **Contract Clinical Trial Analyst **to be in **São Paulo **(remote work).
**Purpose**:Prepare, negotiate, and finalize clinical trial agreements and ancillary agreements for company sponsored and/or investigator-initiated studies through direct negotiation with clinical trial sites or via oversite of a Clinical Research Organization responsible for contract negotiations.
**You will be responsible for**:
- Provide support for negotiations in confidentiality agreements, informed consent forms and other ancillary contract documents as required.
- Participate in discussions related to the development of site/investigator budgets aligned with fair market value.
- Manage the contract amendment lifecycle.
- Assume responsibility for all aspects of legal document and metrics tracking.
- Provide support to review, authorize and/or understand aspects of site payments. Assist clinical operations or clinical team in ensuring that investigator grants comply with overall study costs and compliance guidelines.
- Comply with requests from QA and auditors.
- Work proactively to provide recommendations to improve processes and establish refinements that reduce cycle time, create savings and improve efficiency in the initiation of clinical trial sites.
- Work with the global CCS team as necessary to review and analyze contractual terms to reach resolution. Assess risks of budget and legal provisions in conjunction with members of the CCS team and support functions. Escalate issues as appropriate.
- Exemplary customer focus with vision to drive solutions
**Qualifications**:
- Bachelor’s degree in appropriate scientific or business disciplines
- 3 experience and/or equivalent competencies in pharmaceutical industry/clinical research
- Familiarity with healthcare compliance and other relevant guidance (HIPAA, FCPA, Safe Harbor, etc.) a plus
- Must have a working knowledge of the clinical development process with two (2) years of negotiation and contract experience
- Familiarity with clinical research processes
- Ability to work effectively in cross function teams
- Strong and proven negotiation and problem resolution skills
- Working knowledge of PCs (MS Office suite at a minimum) and database management
- Must demonstrate innovative spirit, have strong interpersonal skills, and ability to manage a high volume of work
- Previous experience working in virtual teams preferred.
DECISION-MAKING AND PROBLEM-SOLVING:
- Adhere to SOPs, ethics and departmental compliance as determined by GD management as well as operating companies, corporate, HCC and QA guidelines. Ensure familiarity with departmental and corporate processes including but not limited to the relevant processes associated with CCS, GD and operating companies. Comply with requests from QA and auditors.
- Comply with requests from QA and auditors.
- Able to work independently as well as in a collaborative team environment.
Other:
- English language is required.
- Travel Percentage: 10%
-
Contract Clinical Trial Senior Analyst
7 meses atrás
Sao Paulo, Brasil Johnson & Johnson Tempo inteiroDiversity, Equity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for more than 130 years. Regardless of your race, belief, sexual orientation, religion, or any other trait, YOU are welcome in all open positions at the largest...
-
Clinical Project Manager
2 semanas atrás
Sao Paulo, Brasil CTI Clinical Trial Services, Inc Tempo inteiro**Clinical Project Manager** **(Level Depends on Experience)** **Job Purpose/Summary**: Responsible for management and oversight of assigned clinical trials (Phase I through Phase IV) to ensure client’s goals of time, budget and quality performance are met. The Clinical Project Manager I is expected to require support and guidance from Directors and/or...
-
Senior Clinical Research Lead
2 semanas atrás
São Paulo, São Paulo, Brasil Cti Clinical Trial Services, Inc Tempo inteiroAbout CTI Clinical Trial Services, IncCTI Clinical Trial Services, Inc is a leading contract research organization (CRO) dedicated to advancing medicine through clinical trials. Our team of experts works tirelessly to ensure the highest quality results and exceptional patient care.We value our employees as the backbone of our success, providing a supportive...
-
Senior Site Contract Analyst
2 semanas atrás
Sao Paulo, Brasil Johnson & Johnson Tempo inteiroResponsible for the development and analysis of contractual relationships including investigator grants including but not limited to drafting, negotiating, and finalizing agreements related to clinical trials and/or overseeing a Clinical Research Organization responsible for contract negotiations. Provide support to the clinical team in the pricing,...
-
Clinical Trials Analyst Ii
4 meses atrás
São Paulo, SP, Brasil Thermo Fisher Scientific Tempo inteiro**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **As a Clinical Trials Analyst II at Thermo Fisher Scientific Inc., you will have the unique opportunity to lead and support our clients in the flawless execution of logistics for clinical trials. Join our extraordinary team in São Paulo and play an important role in ensuring the...
-
Clinical Project Assistant
1 semana atrás
Sao Paulo, Brasil CTI Clinical Trial Services, Inc Tempo inteiro**Clinical Project Assistant** **Job Purpose/Summary** Responsible for supporting management efforts of Clinical Project Managers and Directors, ensuring timelines, and quality standards are being achieved. **What You’ll Do** - Support Clinical Project Manager / Director in completing management activities; supports activities through all phases of a...
-
Clinical Trials Biotech Manager
Há 2 dias
São Paulo, São Paulo, Brasil Medpace Tempo inteiroMedpace, a leading Contract Research Organization (CRO), is continuously expanding its Clinical Trial Management Group in Brazil. We offer remote work options for experienced professionals.Therapeutic Areas of FocusOncology, Cardiovascular/Metabolic, Infectious Disease, CNS, and more are the key areas of focus for our team.We strive to provide flexibility...
-
Clinical Trial Educator
7 meses atrás
Sao Paulo, Brasil Novasyte Tempo inteiroJob Overview The Clinical Trial Educator (CTE) will provide information and education on clinical trial inclusion and exclusion criteria to trial coordinators and healthcare providers. Also provides in-service presentations with the goal to increase patient enrollment. Works in partnership with CRAs and other field-based medical teams for optimal trial...
-
Clinical Trial Manager
7 meses atrás
Sao Paulo, Brasil Novasyte Tempo inteiroClinical Trial Manager - Sponsor Dedicated. Trial Management services provide local management of a clinical trial (s) (or Medical Affairs data generation activity) in a country or countries. Services/deliverables include operational oversight of assigned project(s) at the country level for end-to-end project management from start-up through to closeout...
-
Clinical Trial Manager
2 semanas atrás
Sao Paulo, Brasil NonStop Consulting Tempo inteiroWould you like to build your career within one of the 10 top CROs in a world? Our client is looking for Clinical Trial manager to join their teams in Argentina and Brazil, giving you flexibility and an opportunity to progress your career! **Requirements**: Completed degree in a health-related field; Experience in Phases 1-4 (Phases 2-3 preferred) 3+ years...
-
Clinical Trials Assistant
1 semana atrás
Sao Paulo, Brasil IQVIA LLC Tempo inteiroClinical Trials Assistant Apply locations: São Paulo, BrazilTime type: Full timePosted on: Posted 3 Days AgoTime left to apply: End Date: January 6, 2025 (18 hours left to apply)Job requisition id: R1459764Job OverviewPerform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a...
-
Global Trial Leader
2 semanas atrás
Sao Paulo, Brasil Johnson & Johnson Tempo inteiroAt the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found. The Global Trial Leader (GTL) will have primary global...
-
Clinical Trial Project Manager
4 semanas atrás
Sao Paulo, Brasil buscojobs Brasil Tempo inteiroMedpace is the leading CRO for Biotech companies and is continuing to add established Clinical Trial Managers / Project Managers to join our Clinical Trial Management Group in Sao Paulo, Brazil . Our therapeutic areas of focus include Oncology, Cardiovascular/Metabolic, Infectious Disease, CNS and more. We provide remote flexibility with relevant...
-
Clinical Trial Manager
Há 2 dias
São Paulo, Brasil ICON plc Tempo inteiroClinical 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 Clinical Trial Manager...
-
Clinical Trial Coord
Há 6 dias
Sao Paulo, Brasil Thermo Fisher Scientific Tempo inteiroOur team of colleagues in clinical research services are at the forefront of getting cures to market. We bring a high caliber of scientific and clinical expertise to the development of drugs that address the world’s most challenging health concerns. Our Clinical Research team, who powers our PPD® clinical research portfolio, are part of our leading global...
-
Clinical Trial Manager
1 semana atrás
São Paulo, Brasil ICON plc Tempo inteiroClinical Trial Manager - Argentina, Buenos AiresICON 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 Clinical Trial Manager...
-
Clinical Trials Assistant 1
Há 4 dias
Sao Paulo, 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 Trials Assistant 1
Há 2 dias
Sao Paulo, Brasil IQVIA Tempo inteiroJob 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 Trials Assistant 1
7 meses atrás
Sao Paulo, Brasil IQVIA Tempo inteiroJob 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...
-
Regulatory Affairs Analyst
7 meses atrás
Sao Paulo, Brasil Novo Nordisk Tempo inteiroRegulatory Affairs Analyst (Clinical Trials) **Category**:Reg Affairs & Safety Pharmacovigilance**Location**:São Paulo, São Paulo, BR- **The Position**- Your responsabilities includes: - Develop Informed Consent Forms and regulatory dossiers for initial submissions, amendments, and notifications. - Manage the submission and approval process for trial...