We’re expanding our capabilities across Latin America, and we’re hiring a Senior Clinical Research Associate to support critical studies across Argentina!

As a Senior CRA you'll posses a wide-ranging and broad experience handling our most complex and advanced assignments. Responsibilities will be dependent upon the type and timing of the program to which the Senior CRA is assigned and will, at a minimum, include start-up and study implementation activities, on-site monitoring of clinical research studies as well as on-going site management. Incumbents are expected to be able to manage appropriately sized or complex clinical trials, and support Clinical Trial Managers and/or Project Managers with trials as required. An increased focus on training and mentoring junior staff members may be expected.

Responsibilities:

• Independently oversees all aspects of study site management to ensure patient safety is protected, quality of data generated by managed sites resulting in consistently low query levels and in acceptable Quality Assurance reports
• Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions
• Establishes, updates, tracks and maintains study specific trial management tools/systems, and status reports
• Manages site start up procedures including the feasibility and recruitment of potential investigators, preparation of EC/IRB submissions, collection and review of regulatory documents, review and adaptation in Patient Informed Consents, notifications to IRB, EC and regulatory authorities, as appropriate, translation of study related documentation, organization of meetings and other tasks as instructed by the Clinical Trial Manager/Project Manager
• If required, assists the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee
• Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues
• Independently conducts all forms of site visits, including pre-study/qualification, initiation, routine monitoring, and close-out visits, in accordance with the protocol, local laws, ICH-GCP and Precision SOPs. Performs Monitoring Oversight Visits to assess other CRA team members. Prepares and submits for review, accurate and timely monitoring reports from all site visits (on-site and remote)
• Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs, Clinical Monitoring Plan/Site Management Plan and client requirements. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution
• Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations
• Communicates effectively and proactively with both site personnel and Precision's Project and Clinical Trial Management to relay protocol/study issues including any deviations and implements necessary actions in response to those issues
• Develops and maintains good working relationship with investigators and study staff, serving as an ambassador to promote Precision's high quality and professional image
• Performs investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned
• Performs data review activities, including remote EDC CRF and patient profiles review, query resolution, and assists data management and clinical data quality personnel to resolve data discrepancies
• Identifies and processes Serious Adverse Events according to the procedures defined by the study team. Also demonstrates a full understanding of the SAE reporting process
• Identifies site risks and escalates those to Clinical Trial Manager/Project Manager with suggested contingencies. Owns the timely and appropriate resolution of the risk with oversight from project team
• Prepares for and attends Investigator Meetings and/or sponsor face-to-face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements. May prepare or assist in preparation of study-specific presentations/training materials and tools
• Assists the team managers in the preparation and review of protocols and other study documentation
• Supports the design and development of CRFs and clinical trial documents as they pertain to clinical monitoring activities (i.e. operating manuals, monitoring guidelines, etc.)
• Assists with review of clinical study reports
• Functions as a mentor, assisting with the training and developing of new employees and junior monitors
• Interacts with client, participates in proposal activities, including development and client presentations
• Initiates payment requests for investigators
• Travels as necessary according to project needs
• Other job duties as assigned 

Minimum Education & Experience: 

• 4-year college degree or equivalent experience in a scientific or healthcare discipline
• 5 years or more as a CRA in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies
• Significant site management experience or equivalent experience in clinical research
• Ability to communicate both verbally and in writing at the English proficiently (Professional level)

Preferred Education & Experience:

• Graduate, postgraduate degree
• Experience monitoring in rare and complex therapeutic areas
• Experience monitoring EDC trials and EHR records
• Experience in biopharma or relevant therapeutic area
• Relevant site start-up (feasibility, contract negotiations, submissions) experience for the country
• Ability to monitor study sites, with supervision, according to protocol monitoring guidelines, SOPs, GCP and ICH guidelines
• Ability to resolves project related problems and prioritize workload to meet deadlines with oversight from management. Can assist junior CRAs in problem resolution
• Ability to travel overnight. Up to 60% travel on average, based on regional requirements. International travel as needed
• Select opportunities require Oncology experience preferably in early phases
• Exhibits self-motivation and is able to work and plan independently as well as in a team environment.
• Understands clinical trials methodology, including a working knowledge of protocols and indications being studied.
• Demonstrated ability to conduct formal presentations to a wide variety of audiences including colleagues, investigative staff, and clients with a high level of proficiency.
• Demonstrated focus on continuous improvement, including the ability to make proactive assessments on how to make processes more efficient and people more effective.

#LI-AG2 #LI-REMOTE

We’re expanding our capabilities across Mexico, Brazil, Argentina, Colombia, Chile, and Peru, and we’re hiring a Senior Feasibility Associate to join our team at Precision for Medicine!

As part of this team, you'll support the delivery of pre-award, post-award, rescue, and stand-alone-feasibility projects. The Senior Feasibility Associate supports pre-award feasibility projects and support business development and operational strategy teams by conducting global feasibility analyses. The Senior Feasibility Associate supports feasibility projects for newly awarded and/or ongoing clinical trials and supports start-up and clinical teams with site identification. In addition, Senior Feasibility Associate may participate in specific projects that enables Precision for Medicine to stay at the forefront of innovation and maintain their competitive edge as a scientifically driven engaged partner for our biotech and pharma clients.

Essential functions of the job include but are not limited to:

• Support pre-award feasibility projects
• Provide pre-award feasibility analysis and input for pre-award RFPs, including competitive analysis, historical recruitment analysis, standards of care, drug analysis, epidemiology analysis, site and country analysis.
• Review clinical protocols, study assumptions, client information and study plans for US and global trials.
• Present and explain feasibility analysis to BD/Clients, including the process, recommendations, and rationale.
• Interface with colleagues, consultants and partners and collaborate with internal and external sources to gather and share feasibility information.
• Undertake feasibility site outreach for pre award opportunities.
• Participate and/or contribute to BDM and client calls.
• Apply process, templates and delivery standards for feasibility pre-award.
• Provide support to post-award feasibility projects
• Undertake post-award, rescue, and standalone feasibility deliverables in alignment with study and client requirements.
• Provide management of feasibility project team pertaining to the conduct of the feasibility:
• Provide training and training materials.
• Ensure accuracy and quality of the survey data.
• Oversee and /or conduct the site outreach process.
• Participate and or/contribute to feasibility KOM and feasibility progress meetings with the sponsor.
• Where appropriate, engage with patient advocacy groups and site networks to support study feasibility, recruitment, and successful delivery.
• Support the analysis of the collected site data to provide accurate site identification, enrollment modeling and study strategy (ies)
• Apply process, tracking, templates, data structure delivery standards for post award and stand-alone feasibility.
• Work closely with the Precision study teams to assess required input from the feasibility team, and agree on delivery plan, including roles and responsibilities, for feasibility pre- and post-award.
• Follow post and pre award feasibility process, SOPs templates and tools.

Qualifications:
Minimum required:

• Bachelor’s degree in a life sciences discipline
• A minimum of 5 years of related experience
• Combination of qualifications and equivalent relevant experience may be accepted as an alternative.

Other Required:

• Relevant experience in the required activities for the role including feasibility analysis, site identification.
• Domestic and international travel including overnight stays.
• Ability to communicate both verbally and in writing at the English proficiently (Professional level)

Preferred:

• Postgraduate degree preferred.

Skills:

• Strong management and organizational skills
• Excellent oral and written communication skills in English
• Strong rationale and analytical thinking
• Strong IT platform and data analysis skills
• Strong presentation abilitiesAdvanced computer skills, specifically with MS Word, Excel, PowerPoint, and with web/data-based platforms

Competencies:

• Strong sense of ownership and pride in quality of outputs
• Good to strong attention to detail
• Team player
• Willingness to work in a matrix environment, work independently and as part of a dynamic team.
• Demonstrates knowledge of ICH-GCP

We’re expanding our capabilities across Mexico, Brazil, Argentina, Colombia, Chile, and Peru, and we’re hiring a Senior Feasibility Associate to join our team at Precision for Medicine!

As part of this team, you'll support the delivery of pre-award, post-award, rescue, and stand-alone-feasibility projects. The Senior Feasibility Associate supports pre-award feasibility projects and support business development and operational strategy teams by conducting global feasibility analyses. The Senior Feasibility Associate supports feasibility projects for newly awarded and/or ongoing clinical trials and supports start-up and clinical teams with site identification. In addition, Senior Feasibility Associate may participate in specific projects that enables Precision for Medicine to stay at the forefront of innovation and maintain their competitive edge as a scientifically driven engaged partner for our biotech and pharma clients.

Essential functions of the job include but are not limited to:

• Support pre-award feasibility projects
• Provide pre-award feasibility analysis and input for pre-award RFPs, including competitive analysis, historical recruitment analysis, standards of care, drug analysis, epidemiology analysis, site and country analysis.
• Review clinical protocols, study assumptions, client information and study plans for US and global trials.
• Present and explain feasibility analysis to BD/Clients, including the process, recommendations, and rationale.
• Interface with colleagues, consultants and partners and collaborate with internal and external sources to gather and share feasibility information.
• Undertake feasibility site outreach for pre award opportunities.
• Participate and/or contribute to BDM and client calls.
• Apply process, templates and delivery standards for feasibility pre-award.
• Provide support to post-award feasibility projects
• Undertake post-award, rescue, and standalone feasibility deliverables in alignment with study and client requirements.
• Provide management of feasibility project team pertaining to the conduct of the feasibility:
• Provide training and training materials.
• Ensure accuracy and quality of the survey data.
• Oversee and /or conduct the site outreach process.
• Participate and or/contribute to feasibility KOM and feasibility progress meetings with the sponsor.
• Where appropriate, engage with patient advocacy groups and site networks to support study feasibility, recruitment, and successful delivery.
• Support the analysis of the collected site data to provide accurate site identification, enrollment modeling and study strategy (ies)
• Apply process, tracking, templates, data structure delivery standards for post award and stand-alone feasibility.
• Work closely with the Precision study teams to assess required input from the feasibility team, and agree on delivery plan, including roles and responsibilities, for feasibility pre- and post-award.
• Follow post and pre award feasibility process, SOPs templates and tools.

Qualifications:
Minimum required:

• Bachelor’s degree in a life sciences discipline
• A minimum of 5 years of related experience
• Combination of qualifications and equivalent relevant experience may be accepted as an alternative.

Other Required:

• Relevant experience in the required activities for the role including feasibility analysis, site identification.
• Domestic and international travel including overnight stays.
• Ability to communicate both verbally and in writing at the English proficiently (Professional level)

Preferred:

• Postgraduate degree preferred.

Skills:

• Strong management and organizational skills
• Excellent oral and written communication skills in English
• Strong rationale and analytical thinking
• Strong IT platform and data analysis skills
• Strong presentation abilities
• Advanced computer skills, specifically with MS Word, Excel, PowerPoint, and with web/data-based platforms

Competencies:

• Strong sense of ownership and pride in quality of outputs
• Good to strong attention to detail
• Team player
• Willingness to work in a matrix environment, work independently and as part of a dynamic team.
• Demonstrates knowledge of ICH-GCP

#LI-AG2 #LI-REMOTE

We’re expanding our capabilities across Mexico, Brazil, Argentina, Colombia, Chile, and Peru, and we’re hiring a Safety Specialist to join our growing team!

The Safety Specialist is an integral part of the safety team and performs all aspects of the collection, processing, and reporting of individual case safety reports (ICSR) for clinical trials and/or post‑marketing programs.

Main Duties & Responsibilities:

• Process ICSRs according to SOPs and project-specific safety plans
• Triages ICSRs, evaluates data for completeness and regulatory reportability
• Enter data into Argus Safety Database
• Code events, medical history, concomitant meds, and tests
• Draft case narratives
• Query resolution and follow‑up until complete
• Generate timely expedited regulatory reports
• Coordinate reconciliation of safety and clinical databases
• Ensure required safety reports distribution
• Participate in audits/inspections
• Submit documents to TMF/PV System MF
• Maintain compliance with SOPs, GCP, ICH, GVP, regulations
• Attend department meetings
• Participate in project meetings
• Other duties as assigned

Education and Experience:

Minimum Education & Experience:

• Minimum 2 years clinical trial drug safety experience; Bachelor’s degree in Pharmacy, Nursing, Life Science, or equivalent. Experience with Argus Safety Database, MedDRA, WHODrug, FDA/EMA/ICH safety regulations
• Professional working proficiency in English

Preferred Education & Experience:

• Early phase oncology experience preferred

Knowledge, Skills, and Competencies:

• Strong knowledge of safety reporting requirements and guidelines
• Ability to analyze and evaluate clinical safety data
• Strong written communication and narrative writing skills
• Experience with Argus, MedDRA, WHODrug
• Strong attention to detail
• Ability to manage multiple cases and deadlines

We’re expanding across Mexico, Brazil, Argentina, Colombia, Chile, and Peru and seeking a Clinical Systems Administrator to join our growing team!

The primary responsibility of the Clinical Systems Administrator is to provide business administration support for the Sponsor’s clinical systems, including but not limited to eTMF/CTMS, IRT and EDC systems (i.e., Veeva Clinical Vault and Medidata CTMS). The Clinical Systems Administrator will work with the Clinical Systems leadership and Project teams to ensure on-time deliverables and provide clinical systems user support as outlined below.

Essential functions of the job include but are not limited to:

• Responsible for User Access management for internal, sponsor and 3rd party access requests to the Clinical Systems and other business systems.
• Manages the data entry into the Global Directory within Precisions Clinical System of all Sites, Institutions and update as required.
• Manages the creation of studies, countries and sites within the Clinical System
• Responsible for resolving help desk tickets assigned, either by answering questions, trouble shoot problems or identify system performance issues or deficiencies.
• Perform Clinical System modifications and updates to picklists, field requirements
• Manages the review of Clinical System processes and procedures
• Supports with initiating the integrations between the Clinical system and Electronic Data Capture system
• Performs archival steps within the Clinical System as the request was received.
• Support the leads or manager in any ad-hoc tasks assigned.

Qualifications:

Minimum Required:

• Degree, or equivalent experience ideally in a business, scientific or healthcare discipline
• 2 years’ clinical trial experience with 2 years of experience with Clinical Systems
• Professional working proficiency in English

Other Required:

• Experience in clinical trial systems (e.g., CTMS, EDC, eTMF and RTMS) with detailed understanding of requirements gathering, documentation, configuration and integrations.

Preferred:

• Demonstrate skills in effective communication (written, oral, and presentation) to all levels including end-users, vendors, and Management Teams.
• Possess the ability to effectively communicate business needs to IT technology partners.

Skills:

• Ability to resolve issues independently with good judgement to escalate appropriately.
• Ability to learn new systems and integration requirements.
• Strong interpersonal, verbal and written communication skills

We’re expanding our capabilities across Mexico, Brazil, Argentina, Colombia, Chile, and Peru, and we’re hiring an Associate Compensation & Benefits Director to be responsible for the execution and administration of PMG’s international compensation and benefit plans and programs.

In this role you will be responsible for conducting analysis and interpretation related to the organization’s compensation and benefits programs for region. Supporting international salary survey participation including job matching and competitive benchmarking as well as benefit plan benchmarking. Partnering closely with HR Business Partners, Talent Acquisition, Finance, Legal, and Business Leaders to ensure market competitiveness, internal equity, and compliance across all geographies.

You will also support annual compensation (merit/promotion and bonus) planning process and all international benefit plan management and administration, including benefit plan design benchmarking and broker management.

Main Duties & Responsibilities:

• Member of the global Total Reward team while managing regional compensation and benefits matters in support of the business and local/regional HR Business Partners

Compensation Management

• Participates in annual salary administration programs, including salary grade and structure maintenance & creation
• Provides data analytics for the maintenance and development of incentive or salary increase budgets
• Participates in administration of annual incentive, and/or salary increase programs
• Conducts market benchmarking analysis to determine competitive positioning of the organizations jobs and pay programs
• Evaluates the organizations job descriptions, providing feedback and consulting to the business as needed
• Participates and manages salary surveys by matching PMG jobs to available salary surveys reference jobs and provides organizational data to these survey providers
• Lead the gender pay gap reporting process (as they become applicable… i.e. UK, France)
• Ensures HR systems are configured/maintained in a way that support overall compensation priorities and policy

Benefits Management

• Supports the development of international benefits strategy and oversee the implementation of such, ensuring the benefits offering is strategically aligned with the business, competitively attractive to employees and is cost effective
• Maintain inventory of all benefit plans and policy documents per country/business unit, including renewal dates, and tracking of costs
• Manage annual carrier/policy renewal process, working with brokers and vendors on contract negotiations and initiating periodic market reviews to ensure benefits are secured on the most competitive terms
• Partner with HR and the applicable business to assess, recommend and establish appropriate market level of benefits when PMG establishes operations in new countries and/or upon acquisition of new companies
• Lead the administration of pension schemes
• Point of contact for incoming benefits related invoices (liaison with Finance for invoice processing)
• Build external relationships and participate in international benefit surveys to ensure PMG remains aware of what other companies are doing in the competitive market
• Partner with field HR to handle employee questions and assist with processes such as leave of absence, sickness, and accidents
• Coordinate with legal team, HR team and outside counsel on immigration matters

General Responsibilities

• Partners with HRIS for ongoing data integrity checks
• Produces HR Metrics related to compensation and offer insights to the Business and HR Teams
• Provides guidance, coaching, mentoring and training to HR Business Partners on compensation-related issues
• Provides input on compensation policy and procedure creation
• Generate compensation metrics and provide analysis and recommendations based on them
• Lead and/or participates in HR and Total Reward projects
• Supports US and Global compensation matters as needed

Minimum Education & Experience:

Bachelor's degree in a related major and 12 or more years of compensation and benefits experience within mature international organizations. Experience working across different countries and general understanding of process, payroll and labor law differences.

Expertise in messaging to support compensation and benefit programs that are aimed at leadership and employees.

Preferred Education & Experience:

• Experience in Life Sciences, Pharmaceutical or other industry directly related to one of PMG’s service lines.
• Experience with PayFactors and SAP/SuccessFactors HRMS a plus.
• Experience matching jobs, as well as designing and developing a salary grade structures.
• Has worked with short term incentive plans and/or sales plans.

Or equivalent combination of education, professional training and experience that provides the individual with the required knowledge, skills, and abilities to perform the job.

Knowledge, Skills, and Competencies:

• Bias for Action & Ownership: Is a “self-starter”. Proactively identifies issues; takes end-to-end accountability for outcomes
• Advanced proficiency with market pricing, survey methodology, salary structures, regression analysis, and data modeling
• Solid understanding of global regulatory environments and pay transparency legislation
• Good understanding of different cultures (both business as well as country) and demonstrates an appreciation of cultural diversity, with sensitivity to differences in attitudes and norms
• Data Analytics & Storytelling: Translates data into insights and executive-ready narratives
• Influence Without Authority: Shapes outcomes across HR, Finance, Legal, and business leaders through credibility and relationships
• Strategic Thinking & Execution: Operates at both 30,000 ft and ground level; delivers polished programs on time
• Stakeholder Management & Communication: Tailors messages to diverse audiences; simplifies complexity
• Change Leadership & Enablement: Drives adoption of new frameworks and practices through training, playbooks, and clear guidance
• Project Management Excellence: Demonstrates ability to plan, organize, and execute complex global compensation projects. Effectively manages timelines, resources, and stakeholders; communicates progress clearly; and ensures successful delivery of initiatives within scope, budget, and quality standards

#LI-AG2 #LI-REMOTE