Farmacéutico/A Comunitario: Crecimiento Y Bienestar

Farmacias-Central-Oeste; Buenos Aires; A distancia; ARS 1.800.000 - 2.400.000; Jornada completa

Descripción de la vacante

Farmacias-Central-Oeste is seeking an experienced Senior Clinical Site Activation professional to lead activation and maintenance of clinical studies. You will coordinate with Regulatory, QA, and cross-functional teams to ensure compliant and timely study startup and ongoing maintenance.

The role requires strong negotiation, excellent communication and interpersonal skills, and the ability to manage international projects with a 50% travel requirement.

Formación

• 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

Responsabilidades

• Oversee the execution of Site Activation and/or Maintenance for assigned projects, ensuring timelines are met and documentation is complete.
• Develop and maintain project management plans, schedules and budgets in collaboration with cross-functional teams.
• Provide regulatory and scientific support to enable study initiation and ongoing maintenance while ensuring compliance with regulatory requirements.
• Mentor colleagues and foster effective communication across regions and teams.

Conocimientos

Advanced English

Negotiation

Communication

Interpersonal skills

Team player

Educación

Bachelor's degree Life sciences

Descripción del empleo

Buesos Aires, Argentina

Full time

R

CRA 2 - Homebased

This role is an ideal stepping-stone. You'll have training and development to plan and progress your career in the direction you choose. And you won't do it alone - you will have dedicated mentoring and receive structured quarterly reviews on performance, promotion and bonus awards.

Award winning and innovative, we'll give you access to cutting-edge in-house technology, allowing you to work on global projects but with a regional / home state travel remit, so no need for national travel in certain countries. You'll be building a smart and flexible career with no limits.

While projects vary, your typical responsibilities might include:

• Performing site selection, initiation, monitoring and close-out visits, plus maintaining appropriate documentation
• Supporting the development of a subject recruitment plan
• Establishing regular lines of communication plus administering protocol and related study training to assigned sites
• Evaluating the quality and integrity of site practices - escalating quality issues as appropriate
• Managing progress by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution
• You will need to be comfortable collaborating and communicating with a variety of colleagues and customers. Ideally, you will also have a good basic knowledge of applicable clinical research regulatory requirements.

REQUIREMENTS

You should have:

• A Bachelor's degree in a health care or other scientific discipline or educational equivalent
• At least 2 years of on-site monitoring experience (Mandatory)
• Advanced in English.
• Availability to travel (50% of time)
• Located in Buenos Aires, Argentina.
• Alternatively, you should have an equivalent combination of education, training and experience.

EEO Minorities/Females/Protected Veterans/Disabled

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.

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

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EEO Minorities/Females/Protected Veterans/Disabled