Sr. or Clinical Trial Manager Ii, Oncology;
hace 2 semanas
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.
- BS/BA (or equivalent) in one of the life sciences plus a minimum of 4 years direct experience in clinical studies
- Minimum of 2 years as a successful Clinical Trial Manager; or > 4 years for a Senior Clinical Trial Manager.
- Prior experience as a Clinical Research Associate. (strongly preferred)
Our Trial 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
-
Clinical Research Associate Ii
hace 1 semana
Buenos Aires, Argentina PSI CRO A tiempo completoCompany Description We are the company that cares - for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 2,500 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those...
-
Sr. Associate-Trial Capabilities | Clinical Research-Clinical Operation
Encontrado en: Talent AR C2 - hace 2 semanas
Buenos Aires, Argentina Lilly A tiempo completoWe’re looking for people who are determined to make life better for people around the world. The Trial Capabilities Associate provides clinical trial capabilities in support of clinical development. The associate is accountable to ensure the investigator sites meet requirements to enroll study participants into clinical trials and support ongoing...
-
Sr Clinical Trial Manager, Cardiovascular, Rare
hace 5 días
Buenos Aires, Argentina Novasyte A tiempo completoExperience managing clinical trials in LATAM and North America(REQUIRED) - Strong Cardiovascular Therapeutic experience - 3+ years of Clinical Trial Management experience (CRO experience preferred) BASIC FUNCTIONS: Responsible for the successful planning, implementation and execution of contracted clinical monitoring activities. Functionally responsible for...
-
Sr Clinical Trial Manager, Cardiovascular, Rare
hace 4 días
Buenos Aires, Argentina IQVIA A tiempo completo** Experience managing clinical trials in LATAM and North America(REQUIRED)**: - ** Strong Cardiovascular Therapeutic experience**: - **3+ years of Clinical Trial Management experience (CRO experience preferred)** **BASIC FUNCTIONS**: Responsible for the successful planning, implementation and execution of contracted clinical monitoring activities....
-
Clinical Trial Manager
hace 4 días
Buenos Aires, Argentina Bristol Myers Squibb A tiempo completoEn Bristol Myers Squibb, nos inspira una sola visión: transformar la vida de los pacientes a través de la ciencia. En oncología, hematología, inmunología y enfermedades cardiovasculares, y una de las líneas de producción más diversas y prometedoras de la industria, cada uno de nuestros apasionados compañeros contribuye a innovaciones que impulsan...
-
Clinical Trial Administrator II.
Encontrado en: Talent AR C2 - hace 3 semanas
Buenos Aires, Argentina PSI A tiempo completoJob Description Join our international team and be the key support to clinical research projects, streamlining communication, maintaining systems and managing documents & information. Hybrid position in Buenos Aires, Argentina Only CVs in English will be accepted. You will be responsible for: Customization of Site ICF/patient documents before...
-
Clinical Trial Administrator II
Encontrado en: Talent AR C2 - hace 5 días
Buenos Aires, Argentina PSI CRO A tiempo completoJob DescriptionJoin our international team and be the key support to clinical research projects, streamlining communication, maintaining systems and managing documents & information. Hybrid position in Buenos Aires, ArgentinaOnly CVs in English will be accepted.You will be responsible for:Customization of Site ICF/patient documents before sending it to...
-
Local Clinical Trial Assistant
hace 2 días
Buenos Aires, Argentina IQVIA A tiempo completo**Are you a brave mind?** It takes insight, curiosity, and intellectual courage to transform healthcare. It takes brave minds. By reimagining a world without the consequences of disease, brave minds bring powerful ideas to reality. Not intimidated by complexity, they see possibilities and explore the improbable. **Join us as a **Clinical Trials...
-
Clinical Trial Assistant
hace 3 semanas
Buenos Aires, Argentina Medpace, Inc. A tiempo completoJob Summary: Our global activities are growing rapidly, and we are currently seeking a full-time, office-based Clinical Trial Assistant to join our Clinical Operations team in Argentina. This position will work in a team to accomplish tasks and projects that are instrumental to the company’s success. If you want an exciting career where you use your...
-
Sr CRA
Encontrado en: Talent AR C2 - hace 2 semanas
Buenos Aires, Argentina Thermo Fisher Scientific A tiempo completoMonitors investigator sites with a risk-based monitoring approach, applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through...
-
Sr Clinical Research Associate I
hace 2 semanas
Buenos Aires, Argentina PSI CRO A tiempo completoCompany Description We are the company that cares - for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 2,500 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those...
-
Trial Capabilities Assistant
hace 14 horas
Buenos Aires, Argentina Lilly A tiempo completoAt Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our...
-
Trial Capabilities Associate
hace 14 horas
Buenos Aires, Argentina Lilly A tiempo completoAt Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our...
-
Trial Capabilities Associate Jr
hace 4 días
Buenos Aires, Argentina Lilly A tiempo completoAt Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...
-
Clinical Research Manager
hace 4 días
Buenos Aires, Argentina Fortrea A tiempo completoAs 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...
-
Senior Clinical Trial Administrator
hace 5 días
Buenos Aires, Argentina PSI CRO A tiempo completoCompany Description PSI is a leading Contract Research Organization with more than 25 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications. **Job Description**: Join our international team and be the...
-
Clinical Research Associate
hace 4 días
Buenos Aires, Argentina PSI CRO A tiempo completoCompany Description We are the company that cares - for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 2,500 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those...
-
Sso Clinical Project Manager
hace 6 días
Buenos Aires, Argentina Novartis A tiempo completo100,000. That’s how many patients participate in our clinical trials at any given time. Global Clinical Operations (GCO) touches patients’ lives every day acting as a link between science and medicine. Envision the impact you could have! #GCO The SSO Clinical Project Manager (CPM) is accountable for the day-to-day planning, executing and reporting, (from...
-
Clinical Research Manager
Encontrado en: Talent AR C2 - hace 2 semanas
Buenos Aires, Argentina Fortrea A tiempo completoAs 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...
-
Senior Clinical Research Associate I
hace 1 semana
Buenos Aires, Argentina PSI CRO A tiempo completoCompany Description We are the company that cares - for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 2,500 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those...