Senior Study Start Up Associate Job at iconplc (São Paulo)

Senior Clinical Research Associate

As a Clinical Research Associate (CRA) at Parexel, you act as an integral part t...

Location

United States

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Excellent attention to detail
Good written and verbal communication skills
Good collaboration and interpersonal skills
Good negotiation skills
Proficient in written and spoken English language required
Fluency in local language(s) required
Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP
Good knowledge of relevant local regulations
Good medical knowledge and ability to learn relevant Client Therapeutic Areas
Basic understanding of the drug development process

Job Responsibility

Contributes to the selection of potential investigators
In some countries, as required, accountable for study start-up and regulatory maintenance
Trains, supports, and advises Investigators and site staff in study related matters, including Risk Based Quality Management (RbQM) principles
Confirms that site staff have completed and documented the required training appropriately
Actively participates in Local Study Team (LST) meetings
Contributes to National Investigators meetings, as applicable
Initiates, monitors, and closes study sites in compliance with Client Procedural Documents
Shares information on patient recruitment and study site progress
Drives performance at the sites
Proactively identifies and ensures timely resolution to study-related issues

What we offer

Patient-focused in everything we do
Supportive and inclusive environment
Career growth and development
Flexible work arrangements
Diverse therapeutic areas and project exposure
Advanced Technology

Fulltime

Senior Director, Head of Argentina Clinical Data Sciences

As part of the Clinical Data Sciences (CDS) group, an integral delivery unit wit...

Location

Argentina , Buenos Aires

Salary:

Not provided

Pfizer

Expiration Date

Until further notice

Requirements

University or college degree in life science, computer science, pharmacy, nursing, or equivalent relevant degree. Advanced degree preferred
Ideally 20 or more years’ experience in drug development with at least 10 years in Clinical Data Management
At least 10 years' line management or global project team leadership experience
Clinical development and business experience in order to have a thorough understanding of regulatory processes at a global level
Recognition in peer community as expert and leader in topic area
Ability to leverage network to establish/maintain contact with scientific community
Exceptional technical and problem solving skills, and ability to evaluate computer systems for Data Management
Excellent understanding of clinical trials methodology, GCP and medical terminology
Experience of interaction with major regulatory authorities (not only in India)
Ability to work under pressure, demonstrating a high level of initiative and flexibility

Job Responsibility

Within CDS, lead a regional team comprised of multiple specialized functions and the local resources supporting and/or leading global trials across multiple TAs
Lead and influence across R&D on behalf of their TA Group or Function as a key component of cross-functional R&D planning
Build a brand-new and/or foster CDS departmental presence that has a strong local culture while being a fully integrated member of the worldwide CDS organization
Develop a departmental roadmap starting with the departmental vision, defined through targeted outcomes, strategic initiatives, and tactical deliverables
Ensure strong partnerships within global CDS, across R&D through collaborations with senior leaders (SVP, VP, ED and SD), senior level stakeholders and with external vendors
Act as a thought leader with the network to drive innovation within the organization and across the industry. Lead the conversation in key industry forums through presentations and publications
Lead clinical and non-clinical cross-functional special projects aimed to evolve CDS and partner functions in line with the Pfizer organization and the changing industry landscape
Set current and future strategy as a core member of the CDS Leadership Team
Span of control of 50 or more people or equivalent in terms of functional areas of accountability
As requested, deputize for the responsibilities of the Global Head of CDS

Fulltime

Senior Clinical Trial Manager

ICON plc is a world-leading healthcare intelligence and clinical research organi...

Location

Mexico , Mexico City

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

A minimum of 5 years of experience as a Senior Clinical Trial Manager, ideally having progressed through CTM I and CTM II, for a total of 7+ years of CTM experience
Strong experience managing North America and Canada, including: ICF creation
Advarra IRB
Local IRB management
Canada MOH submissions
Demonstrated experience managing LATAM studies end-to-end, from Start-Up through Close-Out
Excellent English proficiency (reading, writing, and speaking)
Bachelor’s degree in health, life sciences, or another relevant field

Job Responsibility

Budget Oversight Oversee the clinical portion of the budget to ensure efficient resource allocation
Ensuring Effective Study Oversight: Develop monitoring plans and tools, ensuring effective study oversight
Optimizing Performance: Train and mentor Clinical Research Associates (CRAs) to optimize their performance
Timely Study Start-Up & Enrollment: Drive enrollment and lead study start-up activities, adhering to timelines
Improving Study Integrity Review trip reports and implement corrective and preventative action plans when necessary
Building Productive Relationships: Foster productive relationships with Sponsors, vendors, and cross-functional teams

What we offer

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

Senior Clinical Trial Manager

ICON plc is a world-leading healthcare intelligence and clinical research organi...

Location

Brazil , Sao Paulo

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

A minimum of 4+ years of experience in a Clinical Trial Management position at a CRO or Pharmaceutical Organization
Bachelor's degree in health, life sciences, or other relevant fields of study
At least 10+ years of relevant experience in clinical trial management
Preferred: 2+ years of monitoring experience
Experience in managing complex or global trials is advantageous
Preferred: Experience in managing all trial components from start-up to database lock
Preferred: Experience in coaching/mentoring other CTMs, leading a team of CTMs, and participating in departmental initiatives
Fluency in English (reading, writing, speaking)

Job Responsibility

Budget Oversight Oversee the clinical portion of the budget to ensure efficient resource allocation
Ensuring Effective Study Oversight: Develop monitoring plans and tools, ensuring effective study oversight
Optimizing Performance: Train and mentor Clinical Research Associates (CRAs) to optimize their performance
Timely Study Start-Up & Enrollment: Drive enrollment and lead study start-up activities, adhering to timelines
Improving Study Integrity Review trip reports and implement corrective and preventative action plans when necessary
Building Productive Relationships: Foster productive relationships with Sponsors, vendors, and cross-functional teams

What we offer

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

Senior Clinical Trial Manager

ICON plc is a world-leading healthcare intelligence and clinical research organi...

Location

United States , Boston

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

A minimum of 4+ years of experience in a Clinical Trial Management position at a CRO or Pharmaceutical Organization
Bachelor's degree in health, life sciences, or other relevant fields of study
At least 10+ years of relevant experience in clinical trial management
Fluency in English (reading, writing, speaking)

Job Responsibility

Budget Oversight Oversee the clinical portion of the budget to ensure efficient resource allocation
Ensuring Effective Study Oversight: Develop monitoring plans and tools, ensuring effective study oversight
Optimizing Performance: Train and mentor Clinical Research Associates (CRAs) to optimize their performance
Timely Study Start-Up & Enrollment: Drive enrollment and lead study start-up activities, adhering to timelines
Improving Study Integrity Review trip reports and implement corrective and preventative action plans when necessary
Building Productive Relationships: Foster productive relationships with Sponsors, vendors, and cross-functional teams

What we offer

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

Associate Director, Clinical Operations

We are seeking an Associate Director, Clinical Operations who will be accountabl...

Location

United States

Salary:

180000.00 - 195000.00 USD / Year

Apogee Therapeutics

Expiration Date

Until further notice

Requirements

BA/BS in life sciences or equivalent
8+ years of clinical research experience, including at least 3 years leading global projects from inception to completion
2+ years’ experience in Biotech industry strongly preferred
Significant knowledge of pharmaceutical industry, drug development and regulatory processes
Experience developing all Clinical trial plans, including site management, risk assessment and mitigation strategies, recruitment and retention plans, trial budgets and program-level budgets
Leader with growth mindset, willing to learn from others, committed to mentoring others and dedicated to promoting psychological safety
Strong communication skills with ability to present to a variety of stakeholders and tailor message accordingly
Strong project management skills with ability to collaborate effectively cross-functionally and hold team and CRO members accountable to tight timelines and budgets
High sense of urgency and ability to proactively identify critical path items and develop contingency plans to mitigate risk to budget, quality, and/or timelines
Work comfortably in a fast-paced, dynamic work environment and embrace change

Job Responsibility

Accountable for overall management of multiple clinical trials
Serves as the central point of contact and contributes expertise for clinical trial execution on assigned protocols
Works cross-functionally to establish and ensure clinical program timelines and goals are met and risks are appropriately escalated to Clinical Management. Ensures accurate tracking and reporting (dashboard) of study metrics and progress of study through completion
Leads the Clinical Study Team (CST) and may participate in other cross functional program team meetings
Ensures trial adherence to ICH/GCP/Federal and local regulations and company specific SOPs
Responsible for preparing and/or presenting to executive management as delegated
Develops, reviews and/or consults on clinical trial documents, such as study specific plans, informed consent, clinical protocols, Investigator Brochure, CSRs, yearly updates to the regulatory authorities and status updates
May be responsible for participating and presenting at Investigator Meetings, SIVs and other program meetings
Responsible for study level clinical operations budget forecasting, accrual management and quarterly review ensuring tight control between study forecasts and actuals
In conjunction with key stakeholders, oversee and manage the execution and filing of site clinical trial agreements, review of fair market value, CRO and vendor contracts, NDAs, etc

What we offer

A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless
Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly
Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave
Commitment to growing you professionally and providing access to resources to further your development
Apogee offers regular all team, in-person meetings to build relationships and problem solve

Fulltime

Study Delivery Senior Associate

The Study Delivery Senior Associate provides essential global study management s...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Master’s degree
Bachelor’s degree and 2 years of clinical execution experience
Associate’s degree and 6 years of clinical execution experience
High school diploma / GED and 8 years of clinical execution experience
3 years’ work experience in life sciences or medically related field, including 1 year of biopharmaceutical clinical research experience
Experience working on global clinical trials
Strong collaborative and effective communication skills
Expertise in clinical trial processes, operations, and oversight
Strong skills in using MS Word, Excel, PowerPoint
Working knowledge of CTMS, eTMF, EDC, and Microsoft Office tools

Job Responsibility

Lead the development and maintenance of study-level trackers, dashboards, timelines, and tools
Coordinate logistics for investigator meetings, trial events, and site communications
Manage assigned start-up activities
Use study dashboards and reports to monitor global enrollment, data flow, and quality indicators
Lead delivery of assigned risk and quality management activities
Track and report study progress
Deliver assigned components of global recruitment and retention strategies
Manage Study Training system activities and oversight
Build and maintain effective relationships with internal study team members, vendors and investigator sites
Act as a point of contact for routine study updates

What we offer

Reasonable accommodation for individuals with disabilities

Study Delivery Senior Associate

The Study Delivery Senior Associate provides essential global study management s...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Master’s degree
Bachelor’s degree and 2 years of clinical execution experience
Associate’s degree and 6 years of clinical execution experience
High school diploma / GED and 8 years of clinical execution experience
3 years’ work experience in life sciences or medically related field, including 1 year of biopharmaceutical clinical research experience
Experience working on global clinical trials
Strong collaborative and effective communication skills
Expertise in clinical trial processes, operations, and oversight
Strong skills in using MS Word, Excel, PowerPoint
Working knowledge of CTMS, eTMF, EDC, and Microsoft Office tools

Job Responsibility

Lead the development and maintenance of study-level trackers, dashboards, timelines, and tools
Coordinate logistics for investigator meetings, trial events, and site communications
Manage assigned start-up activities
Use study dashboards and reports to monitor global enrollment, data flow, and quality indicators
Lead delivery of assigned risk and quality management activities
Track and report study progress
Deliver assigned components of global recruitment and retention strategies
Manage Study Training system activities and oversight
Build and maintain effective relationships with internal study team members, vendors and investigator sites
Act as a point of contact for routine study updates

What we offer

Reasonable accommodation for individuals with disabilities

Senior Study Start Up Associate

iconplc

Location:
Brazil , São Paulo

Category:
Research and Development

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
March 01, 2026

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