Clinical Development Leader (Medical Monitor) – TCS
Come to one of the biggest IT Services companies in the world! Here you can transform your career!
Why to join TCS? Here at TCS we believe that people make the difference, that's why we live a culture of unlimited learning full of opportunities for improvement and mutual development. The ideal scenario to expand ideas through the right tools, contributing to our success in a collaborative environment.
In this role you will:
This role requires a physician capable of developing and executing oncology clinical trials in support of the successful clinical development, regulatory filing and initial market launch of a growing portfolio of innovative and transformational Oncology agents.
Responsibilities:
* Ensure high quality protocol development aligned with the Clinical Development Plan to effectively determine a medicine’s potential efficacy, safety profile, key areas of product differentiation and value to patient in the shortest possible timeframe.
* Use medical expertise to contribute to the end to end (protocol concept to final study report) to ensure scientific integrity and timely delivery of clinical trials which ensure consistency with the clinical development strategy for regulatory approvals, reimbursable medicines, and successful lifecycle management; demonstrate ability to incorporate global considerations into decision making
* Interpret and summarize study results consistent with objectives to define safety, efficacy, pharmacokinetic/pharmacodynamic, and patient reported outcomes, and applicability of data to the targeted patient population.
* Assume medical responsibility for clinical trials with active participation in real‑time medical monitoring of studies, including patient eligibility assessment, study design questions, and addressing urgent safety questions (with inclusion of Safety/ PV as relevant).
* Assume responsibility for medical review of clinical trial data, both directly as needed and/or via oversight of delegated medical review. Oversee blinded review of data packages intended for IDMCs.
* Review/monitor safety data in collaboration with pharmacovigilance group for active clinical studies.
* Participate in the authoring of clinical study reports and regulatory documents and collaborate with colleagues in Regulatory Affairs, CMC, Toxicology, Research, Pharmacology to respond to health authority and ethics committee queries.
* Collaborate with Principal Investigators in the evaluation and assessment of publications (abstracts, posters, manuscripts) associated with clinical data.
* Network extensively to develop long‑term strategic partnerships with thought leaders both internally and externally, in support of company’s vision.
* Understand biological mechanisms, clinical strategy, scientific interpretation of disease and target‑based literature.
* Serve as a core member of the Clinical Matrix Team for one or more assets in development.
* Represent Clinical Development on disease area strategy, integrated evidence and medical affairs strategy teams.
* Participate in Oncology Clinical Development‑wide initiatives and workstreams as appropriate.
We have some requirements:
* Licensure to practice medicine
* Hands‑on experience in Oncology
* 10+ years of experience in pharmaceutical/biotechnology industry or related clinical experience
* Documented academic and/or clinical research publication history or history of medical practice in a relevant field
* Strong working knowledge of the clinical drug development process with experience in the conduct/participation of clinical trials (investigator initiated, company sponsored or cooperative group trials) and their subsequent publications.
* Knowledge of regulatory requirements to support registration, including knowledge and adherence to GCP principles
What do we offer?
* Health insurance
* Life insurance
* Totalpass
* TCS Cares – free 0800 that provides psychological assistance (24 hrs/day), legal, social and financial assistance to associates
* Partnership with SESC
* Reimbursement of Certifications
* Free TCS Learning Portal – Online courses and live training
* International experience opportunity
* Discount Partnership with Universities and Language Schools
* Bring Your Buddy – By referring people you become eligible to receive a bonus for each hire
* TCS Gems – Recognition for performance
* Xcelerate – Free Mentoring Career Platform
* Tata Consultancy Services is an equal opportunity employer, our commitment to diversity & inclusion drives our efforts to provide equal opportunity to all candidates who meet our required knowledge & competency needs, irrespective of any socio‑economic background, race, color, national origin, religion, sex, gender identity/expression, age, marital status, disability, sexual orientation or any others. We encourage anyone interested to build a career in TCS to participate in our recruitment & selection process.
At TATA Consultancy Services we promote an inclusive culture, we always work for equity. This applies to Gender, People with Disabilities, LGBTQIA+, Religion, Race, Ethnicity. All our opportunities are based on these principles. We think of different actions of inclusion and social responsibility, in order to build a TCS that respects individuality. Come to be a TCSer!
Trilingual Clinical Trial Enrollment Liaison – ICON plc
Home based role
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 Trilingual Clinical Trial Enrollment Liaison to join our diverse and dynamic team. As a Clinical Trial Enrollment Liaison at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies.
Must have:
* Ability to travel up to 75%.
* Doctoral degree (M.D., PharmD, or PhD) is required.
* Fluent in Spanish, Portuguese, and English (trilingual).
What to bring to the role:
* A scientific and clinical network and networking skills
* Demonstrated success in persuasion, influence, and negotiation
* Ability to discuss and apply technical/scientific/clinical knowledge
* Strong communication and presentation skills in local medical language(s)
* Knowledge of local healthcare landscape
* Business, technical, and analytical skills
* Willingness and flexibility to learn new Therapeutic Areas and products
* Cultivate relationships and recruit the most appropriate sites to participate in trials
* Critical thinking and operational expertise
* Fluency in English and local country language
Your experience:
* Experience in a clinical research environment in Pharma, Biotech, or CRO in scientific and/or clinical operations is preferred
* Broad scientific and medical knowledge with an understanding of clinical development
* Excellent interpersonal skills with the ability to develop relations with internal and external stakeholders
* Proactive and self‑motivated with the demonstrated ability to work collaboratively and independently.
What ICON can offer you:
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well‑being and work life balance opportunities for you and your family. Our benefits examples include:
* Various annual leave entitlements
* A range of health insurance offerings to suit you and your family's needs.
* Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
* Global Employee Assistance Programme, LifeWorks, offering 24‑hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well‑being.
* Life assurance
* Flexible country‑specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here.
Project Management Specialist – Clinical Trial Department
Antes de postularse para un puesto, seleccione su preferencia de idioma de las opciones disponibles en la parte superior derecha de esta página. Explore su próxima oportunidad en una compañía perteneciente a la lista de Fortune Global 500. Visualice posibilidades innovadoras, disfrute de nuestra enriquecedora cultura y trabaje con equipos talentosos que lo ayudarán a ser mejor cada día. Sabemos lo que se necesita para llevar a UPS al mañana: personas con una extraordinaria combinación de habilidad y pasión. Si tiene las cualidades y el ímpetu para liderear equipos, hay posiciones listas para cultivar sus habilidades y llevarlo al siguiente nivel.
Descripción de puesto:
* The main purpose of the Project Management Specialist role is the overall responsibility for the successful planning, execution, monitoring, control and closure of clinical supply and/or patient centric services projects.
Main Duties and Responsibilities
1. The role is highly people oriented and entails dealing directly with clients and internal operational departments for setup and implementation of projects including but not limited to the following scope:
o Patient Centric Services (e.g. Home Healthcare visits, Direct‑to/from‑Patient shipments),
o Storage and Distribution of supplies (ancillaries as well as medicinal products, such as Investigational Medicinal Product (IMP), Non‑Investigational Medicinal Product (NIMP), Active Pharmaceutical Ingredients (API), Standard of Care (SoC) Commercial Product, Product(s) for Named Patient Programs (NPPs)) to investigator sites, local and regional depots, HHC providers and clinical trial participants
o Expanded Access Programs
2. The role necessitates taking ownership of the project. This involves providing the client with a primary contact point and acting as the "project owner" to coordinate the internal operational and quality departmental roles in the project.
3. The Project Manager is responsible for managing the project budget and ensuring key study deliverables are maintained in accordance with study contracts. Project activities among others encompass the support of project strategy and feasibility discussions, the creation of a Project Management Plan between Marken and its clients, development of additional project related internal and external forms and work instructions, training of Marken and external project stakeholders, setup of involved system (e.g. Marken inventory, track & trace or Home Health Care system), tracking of project activities and milestones, support with Quality incidents.
4. Other responsibilities include dealing with project enquiries, preparation and maintenance of study reports and KPIs, supporting change order processing and project billing activities, assisting in client audits, developing SOPs and project forecasting.
5. Outside of client project support, the Project Manager is expected to be an engaged member of the Project Management team, contributing to training, business process documentation, departmental activities, and the similar which will improve the department, and Marken, over time.
6. To adhere to all company Policies always.
7. To undertake any other reasonable duties at the request of the Line Manager.
8. Ensure compliance with national and international standards and legislation
9. Travel as reasonably requested by the Line Manager for the performance of duties.
Person Specification
* Title: Project Management Specialist
* Reportable to: Project Manager, Team Lead
* Department: CTD
* Site: LATAM Remote
* Tipo de empleado: Permanente
* UPS se compromete a proporcionar un lugar de trabajo libre de discriminación, acoso y represalias.
#J-18808-Ljbffr