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

Senior Study Start Up Associate

Study Start Up Associate I- IND Submission-Home based-South Korea- ICON Strategi...

Location

South Korea , Seoul

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor's degree in life sciences or a related field
Previous experience in clinical research or regulatory affairs preferred, but not required
Strong attention to detail and organizational skills
Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams
Ability to work independently and manage multiple tasks simultaneously in a fast-paced environment

Job Responsibility

Assisting in the preparation and submission of regulatory documents, such as clinical trial applications and ethics committee submissions
Coordinating with internal and external stakeholders to obtain necessary approvals and authorizations for study initiation
Maintaining accurate and up-to-date records of regulatory submissions and approvals
Supporting study teams in the development of study documents, including protocols, informed consent forms, and investigator brochures
Participating in study start-up meetings and providing input on regulatory requirements and timelines

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

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 OR Bachelor’s degree and 2 years of clinical execution experience OR Associate’s degree and 6 years of clinical execution experience OR 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 obtained working on clinical trials in a biotech, pharmaceutical or CRO company
Experience working on global clinical trials
Strong collaborative and effective communication skills within a team environment
Understands importance of accuracy in documentation, data tracking, and compliance checks
Identifies discrepancies and escalates appropriately
Expertise in clinical trial processes, operations, and oversight in biotech, pharmaceutical, or Contract Research Organization environments
Strong skills in using MS Word, Excel, PowerPoint, and other relevant software for documentation, data management, and trial support
Working knowledge of CTMS, eTMF, EDC, and Microsoft Office tools
Ability to maintain accurate and timely data entry

Job Responsibility

Lead the development and maintenance of study-level trackers, dashboards, timelines, and tools (e.g., vendor management, sample tracking, drug supply planning) to ensure accuracy and visibility
Coordinate logistics for investigator meetings, trial events, and site communications
Manage assigned start-up activities, including system setup, access management, and document readiness, ensuring completion to required standards
Use study dashboards and reports to monitor global enrollment, data flow, and quality indicators, taking proactive action to address deviations and risks
Lead delivery of assigned risk and quality management activities
Track and report study progress, coordinating with Study team and vendors to resolve operational issues and maintain compliance
Deliver assigned components of global recruitment and retention strategies to help ensure enrollment targets are achieved
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, ensuring stakeholders are informed and aligned

Fulltime

Senior Associate Medical Data Reviewer

In this vital role, the Senior Associate - Medical Data Reviewer is responsible ...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

MBBS, MD, PharmD, BDS, BAMS, BHMS, or other relevant medical/healthcare degree with clinical research experience
Master’s degree in Life Sciences, Pharmacy, Public Health, or related field with 5+ years of clinical research experience
Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or related discipline with 7+ years of clinical research experience

Job Responsibility

Conduct ongoing medical review of clinical trial data to ensure accuracy, consistency, and clinical relevance
Evaluate adverse events, laboratory data, vital signs, ECGs, imaging, and other key safety and efficacy endpoints
Identify trends, outliers, protocol deviations, and emerging safety signals across studies
Apply medical judgment to distinguish clinically meaningful findings from normal variability
Provide medical input into study start-up activities, including risk assessments and data review strategy
Partner cross-functionally with Clinical Operations, Data Management, Safety, Biostatistics, and vendors to resolve data issues
Contribute to the development and refinement of medical review tools, visualizations, and dashboards (e.g., Spotfire)
Lead or contribute to data review meetings, governance discussions, and issue escalation processes
Author and maintain clear, defensible medical documentation to support inspection readiness
Drive continuous improvement by identifying systemic data quality trends and strengthening review standards and workflows

Start Up Project Manager II- FSP

The Start Up Project Manager is responsible for defining, developing and deliver...

Location

Canada

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Demonstrated clinical research experience
Demonstrated start up experience
Demonstrated project management experience
Global start up experience (Exposure across a minimum of North America, Asia and Europe) across multiple therapeutic areas
Concurrent management of complex processes within and across countries in multiple regions of the world
Technical expertise in the use of software for the management of clinical studies (enterprise project management, off the shelf and custom built) including reporting systems (dashboards with associated medium to complex data analysis)
Expert ability to comprehend status and adapt communications across a diverse audience
Perform critical path analysis across multiple related project plans, will use key performance indicators to assist in driving overall delivery to operational plan across roles
Will use generative artificial intelligence techniques in daily work
Uses risk management techniques as standard to identify and mitigate key project delivery risks

Job Responsibility

Partner with country / site feasibility specialists to incorporate up to date intelligence for the planned countries and sites into the overall start up strategy and site activation plan, most typically on studies with a medium to large country and site footprint
Partner and co-ordinate across teams responsible for regulatory submissions (local and country) and start up functions (e.g. site essential document collection, site contracts and budgets) to align country and site activities, will have ability to form a robust startup strategy and site activation plan for operationally complex studies
The SUPM is responsible for delivering site activations to plan, for the SUPM II this will generally be for studies with higher operational complexity (based on a combination of factors such study design, country and site footprint and the priority of the study)
As part of the responsibility of delivering site activations to plan the SUPM will co-ordinate with many different roles working at the study and country level to oversee progress of the study specific (e.g. Vendor set-up, investigational product supply etc.) or country specific tasks (e.g. Regulatory submissions, importer of record for supplies etc.) that need to be completed in order for site activations in turn to complete
Provide project management of activities directly required to complete all site activations for an assigned study as part of a study management led team to complete all start up activities for a study
Lead start up meetings that facilitate alignment of site selection to activation activities performed by country level start up roles with the endorsed trial optimization plan (by senior leadership)
The SUPM will work with country level start up roles to seek opportunities to accelerate site activations for their study
Accountable for quality and completeness of start up timeline plans at study, country and site level within an enterprise project management (EPM) system
Responsible for creating and overseeing the initial baseline and subsequent snapshots of timeline planning within the EPM system
In conjunction with study management roles is responsible for ensuring consistent participant compensation for sites and institutions taking part in multiple studies concurrently to eliminate knock-on impact across studies

Senior Associate Manufacturing - Continuous Improvement Lead

Join Amgen’s Mission of Serving Patients. In this vital role you will have the o...

Location

United States , Holly Springs

Salary:

86048.05 - 116417.95 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

High school diploma / GED and 4 years of Manufacturing or Operations experience
Associate’s degree and 2 years of Manufacturing or Operations experience
Bachelor’s degree and 6 months of Manufacturing or Operations experience
Masters degree
Educational background in Life Sciences, Chemistry, Biochemistry, Industrial Biotechnology, and/or Engineering
Strong technical knowledge of drug substance processing (cell culture, harvest, chromatography, filtration, buffer compounding) and a broad understanding of related disciplinary areas in bioprocessing
Proficient technical writing and presentation skills
Ability to lead small and large cross-functional meetings efficiently
Knowledge of process improvement or lean fundamentals
Collaborate with staff at all levels in the organization

Job Responsibility

Support the start-up of the Amgen North Carolina (ANC) manufacturing facility
Have ownership and oversight of operational readiness activities in manufacturing areas
Support Standard Operating Procedure (SOP) creation, review, and approval
Specification and purchasing of required equipment and supplies
Design of job aids and work instructions
Advancement of digital tools to support manufacturing operations
Training of staff
Manage and lead the CI program for MFG when plant transitions to operations
Provide technical support and subject matter expertise for manufacturing area
Oversee support and ongoing development of all the manufacturing systems including SOP, TRNQ, MES, QMS records

What we offer

Competitive and comprehensive Total Rewards Plans aligned with local industry standards

Fulltime

Clinical Trials Regulatory Submission Senior Associate

In this vital role you will be responsible for performing Regulatory submissions...

Location

Argentina , Buenos Aires

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Master’s degree
OR Bachelor’s degree and 5 years of Clinical Trials experience
Minimum 3 years of regulatory submissions and/or study start-up experience is required with strong technical knowledge performing Clinical Trial Applications in Argentina (ANMAT, CCIS)
Excellent written and verbal communication skills in English
Experience and/or technical knowledge in Import License extensions is a strong plus
Ability to plan, develop, and manage timelines, including keeping them up to date
Comfortable managing multiple projects and priorities at the same time
Skilled at building and maintaining positive relationships with health authorities, colleagues, managers, and service providers
Able to work independently and asynchronously across time zones in a collaborative, matrixed team environment

Job Responsibility

Performing Regulatory submissions in Argentina to ANMAT/ CCIS
Compiling submission dossier
Execution of all regulatory activities for clinical trial projects and programs, according to local regulations and Amgen’s policy
Interacting directly with Functional Service Providers for Ethics Committee Services, Clinical Project Management (Local Trial Managers), Global Study Operations, International Regulatory Team, CMC Global Product Leads, Pharmacovigilance, Clinical Supply Chain and vendors acting as Importer of Record
Performing efficiently end-to-end Clinical Trials Regulatory submissions in country for new and ongoing project(s) or programs
Submitting, with the input of importer of record, study specific import licenses extensions until approvals
Communicating overall regulatory status to internal teams and service providers
Attending to project meetings with cross functional department leads to provide regulatory timelines and requirements for regulatory submissions and approvals
Collaborating with internal team members to establish timelines and clarify regulatory requirements
Maintaining clinical trial regulatory requirements' database, including regular updates to checklists

What we offer

Competitive and comprehensive Total Rewards Plans that are aligned with local industry standards

Fulltime

Senior Clinical Research Associate

Senior Clinical Research Associate - Oncology - East Coast. ICON plc is a world-...

Location

United States , Atlanta; Texas; Maryland; Missouri; Tennessee; North Carolina; Illinois; Ohio; Florida; Philadelphia, PA

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

An undergraduate degree or it’s equivalent in clinical, science, or health related field from an accredited institution
a licensed health care professional (i.e. registered nurse) or equivalent work experience required
5+ years clinical monitoring experience required (Sr CRA)
Knowledge of ICH and local regulatory authority regulations regarding drug
Read, write and speak fluent English
Oncology monitoring experience required
Experience doing feasibility/site selection/site start up required
To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status

Job Responsibility

Implements and monitors clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and Internation Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines
Assesses the qualification of potential investigative sites, initiates clinical trials at investigative sites, instructs site personnel on the proper conduct of clinical trials, and closes clinical trials at investigative sites
Responsible for site startup activities for assigned sites, including but not limited to regulatory documents collection, informed consent review, IRB/IEC submission support, and budgets and contracts negotiations
Reviews and verifies accuracy of clinical trial data collected, either onsite or remotely
Provides regular site status information to team members, trial management, and updates trial management tools
Completes monitoring activity documents as required by sponsor's SOPs
Works closely with other clinical team members to facilitate timely resolution of trial and/or clinical issues
Escalates site and trial related issues per Sponsor's SOPs until identified issues are resolved or closed
Performs essential document site file reconciliation
Performs source document verification and query resolution

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 Research Associate

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

Location

United States , Remote

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, CRAs are 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 (site quality/performance) within the LST
Drives performance at the sites
Updates CTMS and other systems with data from study sites as per required timelines

What we offer

Flexible work arrangements
Career growth and development
Supportive and inclusive environment
Diverse therapeutic areas and project exposure
Advanced Technology

Fulltime

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Senior Study Start Up Associate

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