Farmacéutico (Olivos)

Swiss Medical Group; Partido de Quilmes; Presencial; ARS 90.595.000 - 135.892.000; Jornada completa

Descripción de la vacante

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence. Direct and manage the delivery of site activation, maintenance and regulatory activities for studies, ensuring timelines and budgets are met.

You will coordinate with Regulatory & Site Activation across regions to deliver the agreed scope and maintain CTMS data with high quality. Join a team that supports feasibility assessments, site lists, and collaboration with investigators,

Formación

• Bachelor's degree in life sciences or related field required.
• 7+ years of relevant experience in scientific or clinical environment.
• Strong knowledge of GCP/ICH guidelines and regulatory requirements.
• Excellent communication and negotiation skills; ability to lead cross-functional teams.
• Proven ability to manage multiple projects with high quality and deadlines.

Responsabilidades

• Coordinate site activation/maintenance activities per project plan.
• Review regulatory documents and manage eTMF/CTMS data.
• Support regulatory submissions and site/start-up processes.
• Maintain relationships with sponsors, sites and internal stakeholders.

Conocimientos

Regulatory Knowledge

Project Management

GCP/ICH Knowledge

Communication

Leadership

Educación

Bachelor's degree Life sciences or related field

Herramientas

MS Office

CTMS

Clinical trial databases

Descripción del empleo

São Paulo, Brazil
Buenos Aires, Argentina
Bogota, Colombia
Full time
R

Job Overview

Direct and manage the delivery of all required site activation, maintenance and regulatory activities for selected studies or multi-protocol programs, including pre-award activities, oversight of the scope of work, budget and resources.

Essential Functions

• Oversee the execution of Site Activation (including pre-award/bid defense activities) and/or Maintenance for assigned projects in accordance with the agreed RSU site activation strategy, adhering to project timelines. Develop, implement and maintain the Management Plan according to the Scope of Work and Project Plan, within the agreed project strategy, resolving project related issues where required. Ensure collaboration across Regulatory & Site Activation, including communication with regions and countries, to successfully deliver the agreed project scope in compliance with the RSU Management Plan. Create and/or review technical and administrative documentation to support business development and enable study initiation and maintenance, as required. Provide specialist regulatory and technical scientific support to facilitate efficient business development, initiation and maintenance of clinical trials, whilst enabling compliance with regulatory requirements. Provide overall guidance and oversight of multi-regional and multi-protocol programs during initial start-up and maintenance phase as an integral member of the study management team. Determine regulatory strategy/expectations and parameters for submissions and all necessary authorizations
• identify regulatory complexity and challenges and offer creative and practical solutions to support the bid process and subsequent execution of the site activation plan. Assess and review the regulatory landscape and contribute to the collection, interpretation, analysis and dissemination of accurate regulatory intelligence to support assigned studies and wider company, as required. Execute operational strategy/ expectations for maintenance of clinical study approvals, authorizations and review/ negotiation of contracts and essential documents. Work with Quality Management to ensure appropriate quality standards for the duration of site activation (or Maintenance, as applicable). Mentor and coach colleagues as required. Ensure accurate completion and maintenance of internal systems (with emphasis on CTMS), databases, tracking tools, timelines and project plans with project specific information. May take a lead role in developing long standing relationships with preferred IQVIA customers. Deliver presentations/training to clients, colleagues and professional bodies, as required. May be involved in activities related to monthly study budget planning and reviews.

All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.

To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.

EEO Minorities/Females/Protected Veterans/Disabled

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Join Us as a Clinical Trial Coordinator II - Make an Impact at the Forefront of Innovation We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.

As part of our global team, you'll have the opportunity to provide administrative and technical support to the Project Team. As a Clinical Operations Delivery Associate II, you'll support audit readiness by ensuring files are reviewed according to the schedule detailed in the organization's SOP and department guidance document. You will provide administrative support for site activation activities and aid in the development of the critical path for site activation within assigned projects to support rapid site activations. Representing the organization in the global medical research community, you may develop collaborative relationships with investigators and site personnel to conduct feasibility assessments in accordance with feasibility processes and within deliverable timelines. You may develop a local knowledge base of sites in the respective market through collaboratively working with local company personnel. Additionally, you may utilize local knowledge, organization systems, external site lists, and sponsor directives to develop and review site lists that are suitable for the strategic needs of feasibility activities and to provide local input into the site tiering process. You may act as a buddy during the onboarding phase, support training of new staff, and participate in departmental initiatives to aid in process improvements and enhancements.

What You'll Do:

• According to the specific role (Central or Local), coordinates, oversees and completes functions on assigned trial(s) activities as detailed on the task matrix.
• Performs department, Internal, Country and Investigator file reviews as assigned and documents findings in appropriate system(s).
• Ensures allocated tasks are performed on time, within budget and to a high quality standard. Proactively communicates any risks to project leads and line manager as appropriate.
• Performs administrative tasks on assigned trials including but not limited to timely processing of documents sent to Client (e)TMF as assigned, performing (e)TMF reviews, distributing mass mailings and communications as needed, providing documents and reports to internal team members.
• Reviews and tracks local regulatory documents.
• Analyzes and reconciles study metrics and findings reports. Assists with clarification and resolution of findings related to site documentation.
• Maintains vendor trackers.
• Assists with coordination, compilation and distribution of Investigator Site File (ISF) and Pharmacy binder materials and non-clinical study supplies to sites.
• Assists with study-specific translation materials and translation QC upon request.
• Assists with technical and administrative support for projects in collaboration with internal departments and team members.
• Maintains knowledge of and understands SOPs, client SOPs/directives, and current regulatory guidelines as applicable to services provided.
• Ensures that trial status information relating to activities is accurately maintained in the database and current at all times.
• Where applicable, develops and maintains relationship with client local affiliates.
• Champions the inclusion of Strategic Collaboration sites into the process.
• Trains new personnel in processes and systems.
• May support the maintenance of study specific documentation and global support with specific systems, tools and trackers, including, but not limited to, study team lists, tracking of project specific training requirements, system access management for organization/vendor/clients and tracking of project level activity plans in appropriate system. Ensures (e)TMF is up to date by following file review schedules and documenting findings in appropriate system(s).
• May provide system support (i.e., Activate & eTMF).
• May support RBM activities.
• May transmit documents to client and centralized IRB/IEC.
• May attend Kick off Meeting and take notes when required.
• May support scheduling of client and/or internal meetings.
• May support scheduling and organization of client and/or internal meetings with completion of related meeting minutes.
• Provides support as needed to coordinate with internal departments and ensure site start-up activities within the site activation critical path are aligned.
• Assists the project team with the preparation of regulatory compliance review packages.
• May support start-up team in Regulatory submissions.
• Occasionally works directly with site(s) to obtain documents related to site selection.
• May develop site list, including research from internal and external sources to ensure the site list is reflective of the defined site profile. Ensure current investigator and site staff contact details are appropriately maintained in company systems.
• May complete the 'Site Interest Plan' in CTMS and collection and delivery of associated documents from investigators and site personnel. Document in real time all communication, attempts and follow up associated with site contact and survey responses.
• Supports the review of survey data to ensure responses are logical, complete and reflective of the question asked.
• Works in collaboration with teammates to achieve targeted deadlines for assigned projects. Communicate with the team and appropriate clinical personnel regarding site issues and risks.
• Ensures an efficient, effective plan is in place for site contact and follow up. Ensure compliance with the plan and escalates concerns/non-compliance to management.
• May act as the local expert regarding site capacity and experience. Work with key local personnel to gather knowledge base and recommend additional sites. Harnesses this knowledge base when performing local tiering of sites.
• May conduct phone interviews, scripted or non-scripted, with physicians and other site personnel to discuss standard of care and obtain protocol-level input to support trial optimization projects.
• Liaises with Global Investigator Services to resolve investigator queries in real time and maintain 'accounts and contact' information.
• Contributes to the development and roll-out of global strategic feasibility processes and best practices.

Education and Experience Requirements:

• High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification.
• Bachelor's degree preferred.
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 2 years).
• In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:

• Ability to work in a team or independently, as required
• Strong organizational skills and attention to detail, with proven ability to handle multiple tasks efficiently and effectively
• Proven ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency
• Strong customer focus
• Demonstrated flexibility and adaptability to reprioritize workload and provide efficient support to meet changing project timelines
• Demonstrated ability to attain and maintain a good working knowledge of applicable Country
• Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs for all non clinical/clinical aspects of project implementation, execution and closeout
• Excellent English language and grammar skills and proficient local language skills as needed
• Good presentation skills
• Excellent computer skills, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtainknowledge and master all clinical trial database systems
• Ability to successfully complete the organizations clinical training program
• Self-motivated, positive attitude with effective strong interpersonal skills
• Effective oral and written communication skills, with the ability to communicate effectively with medical personnel
• Excellent interpersonal skills
• Strong attention to detail and quality of documentation
• Good negotiation skills
• Good computer skills and the ability to learn appropriate software
• Fluency in local language as well as a good command of the English language and grammar skills
• Basic medical/therapeutic area and medical terminology knowledge
• Ability to work in a team environment or independently, under direction, as required
• Basic organizational and planning skills
• Basic knowledge of local health systems
• Ability to attain and maintain a working knowledge of GCP and applicable SOPs
• Excellent customer focus
• Proven flexibility and adaptability
• Ability to work in a matrix environment
• A proven relationship builder
• An independent thinker
• Ability to manage risk and perform risk escalation appropriately

Working Conditions and Environment:

• Work is performed in an office/ laboratory/clinical/ and/or home office environment with exposure to electrical office equipment.
• Occasional drives to site locations. Potential Occasional travel required.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

EEO Minorities/Females/Protected Veterans/Disabled

Qualifications

• Bachelor's Degree Life sciences or related field Req
• 7 years' relevant experience in a scientific or clinical environment including demonstrable experience in an international role. Equivalent combination of education, training and experience.
• Strong negotiation and communication skills with ability to challenge
• Excellent interpersonal skills and strong team player
• Proven ability to work through others to deliver results to the appropriate quality and timeline metrics on complex projects
• Thorough understanding of regulated clinical trial environment and in depth knowledge of drug development process
• Demonstrated proficiency in using systems and technology to achieve work objectives
• Good regulatory and/or technical writing skills
• Strong knowledge and ability to apply Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines and applicable regulatory guidelines
• Good leadership skills, with ability to motivate, coach and mentor
• Good organizational and planning skills
• Ability to exercise independent judgment taking calculated risks when making decisions
• Good presentation skills
• Proven ability to establish and maintain effective working relationships with co-workers, managers and sponsors.
• Excellent understanding of study financial management
• Proven ability to work on multiple projects balancing competing priorities