Senior Clinical Trial Manager Job at iconplc (Mexico City)

Senior Clinical Research Manager - Network Operations

The Senior Clinical Research Manager (CRM) provides strategic and operational ov...

Location

United States , Brookline; Brighton; Milford; Weymouth; Methuen; Foxborough; Londonderry

Salary:

105400.00 - 130500.00 USD / Year

Dana-Farber Cancer Institute

Expiration Date

Until further notice

Requirements

Bachelor’s Degree required, with a minimum of 7+ years of related experience or Master Degree with 5+ years experience.
Knowledge of cancer as a disease process, cancer treatment modalities, and the clinical trial process.
Experience in protocol development, data compilation and analysis.
Skilled at developing tracking systems to ensure timely data management by the clinical research staff.
Expert knowledge of Federal and State regulations as they relate to research.
Strong interpersonal, organizational and communication skills are required.
Must have computer skills including the use of Microsoft Office and working knowledge of Livelink
EPIC and OnCore applications.
Has expert knowledge of and is fully proficient in ability to execute clinical trials start-up, active and close out phases.
Is fully proficient in their knowledge of clinical research local policy and federal regulation.

Job Responsibility

CLINICAL TRIAL OPERATIONS: Responsible for the oversight of their disease group's clinical trial portfolio and all related regulatory, compliance and performance metrics requirements.
Oversee the processing of protocols through DFCI Institutional Review Board (and other institutions' IRBs) when appropriate.
Collaborate with the DFCI Clinical Trials Office (CTO), the Office for Human Research Studies (OHRS) and the Quality Assurance for Clinical Trials (QACT) to fulfill local and federal requirements governing human clinical trials.
Identify and manage operational, logistical, and regulatory challenges related to the conduct of clinical trials and acts as a leader in overseeing their resolution.
Assist the principal investigator in developing the protocol budget, in collaboration with Research Administration and the Grants and Contracts offices. Work with grant managers and other financial managers in the reporting and accounting of these funds.
Oversees and coordinates the purchase, receipt, inventory and distribution of equipment utilized in the conduct of clinical trials.
Work collaboratively with clinical research administration and grant managers to help monitor and reconcile all study and related grant finances as needed.
Assists the principal investigator in preparing manuscripts for publication.
Collaborate with the DFCI CTO and DF/HCC QACT to develop study forms, database information, and to establish guidelines for monitoring data quality control for PI Initiated studies / Multi-Center Trials
Oversee the subject enrollment, protocol treatment and follow-up care processes for protocol patients.

Fulltime

Manager, Clinical Operations, International

Cabaletta is seeking a Manager/Sr Manager, Clinical Operations, International. R...

Location

Germany; Switzerland

Salary:

Not provided

Cabaletta Bio Inc

Expiration Date

Until further notice

Requirements

Bachelor’s Degree or advanced degree in life sciences or related field
Minimum 4 years of clinical trial management experience including management of study resources, vendors, budgets, supplies, critical path activities, and risk management, within Biotech or pharmaceutical industry or equivalent by experience
Cell therapy experience preferred and/or focus complex therapies
Fluency in English
working proficiency in additional European languages a plus
Experience with early phase, complex trials
Experience managing Contract Research Organizations and other external vendors
Good understanding of European regulatory requirements (EMA, MHRA, etc)
Working knowledge of GCP/ ICH regulatory guidelines
Extensive knowledge of standard industry practices related to study start-up, site management and monitoring, document management, and clinical supply management

Job Responsibility

Provide day-to-day clinical project management oversight of the full range of clinical operations activities associated with clinical trial conduct from protocol development, feasibility/capability assessments, initiation, execution, control, and closure
Perform hands-on activities not outsourced to vendors, as needed
Author study documents and plans such as ICF and study specific plans
Provide input and review of site training materials
Review and provide clinical operations input into relevant clinical documents such as the protocol, investigator brochure, regulatory documents, clinical study reports and other documents and plans as appropriate
Proactively identify risks and lead team members to mitigate risks in a timely fashion
Develop and maintain positive relationships, both internal and external to project, including site personnel (KOLs, PIs, Study Coordinators)
Select and manage vendors
Perform and document study-level Sponsor Oversight of outsourced clinical activities
Execute clinical operations country submission tasks and documents: Review submission pack, coordinate country-specific ethics RFIs, review and update site-specific consent forms

What we offer

health and retirement
PTO
stock option plans

Senior Associate Data Management

The Senior Associate, Data Management, will help drive key business operation in...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Familiarity with Global Clinical Trial Applications, Marketing Authorizations, Regulations, and Regulatory Guidance
In depth understanding of the Veeva Vault system
Good written and verbal communication skills
Detail oriented
Independent time management and prioritization skills
Work efficiently with little support and minimal to no supervision
Ability to work well with others in demanding situations with a positive attitude demonstrating tact, diplomacy, and respect
Critical thinking skills
Appropriate software skills as required
Strong analytical and problem solving, communication and presentation skills

Job Responsibility

Responsible for maintaining data within the Regulatory Information Management (RIM) system
Create and archive clinical trial, marketing application submissions and health Authority correspondence within Amgen’s RIM system
Serve as a Data Management SME within cross-functional collaborative initiatives
Deliver the implementation of new processes within Veeva Vault, XeVMPD, IDMP and other key regulatory initiatives, ensuring alignment with global regulatory standards and business objectives
Provide support on creating, running and analysing reports for data streamline projects
Develop and deliver training materials and presentations to a global audience
Manage the protocol Amendment New Investigator (PANI) submission updates
Manage 1572 forms for FDA submission
Provide support within the global data management team on US Certificate of Pharmaceutical Product (CPP) and EU Certificate of Medicinal Product (CMP) during additional workload periods
Adhere to Amgen processes, policies, guidelines, SOPs and training documentations

What we offer

Competitive and comprehensive Total Rewards Plans aligned with local industry standards

Senior Clinical Research Associate

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

Location

Taiwan , Taipei

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Advanced degree in a relevant field such as life sciences, nursing, or medicine
Extensive experience as a Clinical Research Associate, with a strong understanding of clinical trial processes and regulatory requirements
Proven ability to manage multiple sites and projects simultaneously, with strong organizational and problem-solving skills
Expertise in monitoring practices, data integrity, and site management, with proficiency in relevant clinical trial software and tools
Excellent communication, interpersonal, and stakeholder management skills, with the ability to influence and drive compliance within a complex environment
Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid driver’s license

Job Responsibility

Monitoring clinical trial sites to ensure adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards
Conducting site visits to assess site performance, resolve issues, and provide support to ensure successful trial execution
Collaborating with cross-functional teams to ensure timely and accurate data collection and reporting
Providing training and guidance to site staff and other CRAs to maintain high standards of clinical trial conduct
Building and maintaining effective relationships with site personnel and stakeholders to facilitate smooth trial operations

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 Manager, Statistical Programming

Beam is looking for a highly talented and motivated Senior Manager, Statistical ...

Location

United States , Cambridge

Salary:

155000.00 - 190000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

MS or higher degree in Statistics, Mathematics, or related scientific Discipline
At least 10 years Pharmaceutical/Biotech programming experience
Advanced SAS programming skills and strong Statistical background along with experience with SAS Base, SAS/Macros, SAS/Graph and SAS/Stat
Experience and in-depth knowledge in CDISC including STDM, ADaM and controlled terminologies
NDA or BLA submission experience is required
Excellent organizational skills and ability to prioritize tasks
Excellent communication and interpersonal skills
Experience managing CROs and other data vendors
Knowledge of ICH guidelines, Good Clinical Practices, FDA / EMA / other regulatory authority guidance

Job Responsibility

Participates in statistical programming activities on clinical studies and oversees CROs to generate analysis data sets and tables, listings and figures needed for clinical study reports and regulatory submissions
Reviews and validates SDTM, ADaM analysis datasets and TFLs created by CROs
Works collaboratively and communicates effectively with Biostatistics, Data Management, clinical operations, clinical development, Regulatory and other functions
Manages creating CDSIC SDTM and ADaM datasets, analysis metadata results and Define.xml for Electronic Submission from the clinical database or external data sources
Manages the activities of data summary, statistical analysis, patient profile, safety and efficacy tables, listings and figures using Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL, SAS/ODS and R
Participates and manages the workflow of generating study specific and ad-hoc clinical data listings, summary tables and figures
Partners with Statisticians and other members of the clinical study team, performs ad hoc analysis
Reviews SAP, DMP, CRF, annotated CRF, table shells and other relevant documents by CROs and provides expert feedback from functional perspective
Develops SAS programming infrastructure and programming processes improve data deliverables and ad hoc analyses quality and efficiency
Builds and mentors a team of programmers as needed to support Beam clinical trials and development pipelines

Fulltime

Senior Manager Biostatistics

Amgen is expanding its global Biostatistics capabilities, with Amgen India (AIN)...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree in Statistics/Biostatistics or related subject with high statistical content and at least 8 years of post-graduate statistical experience in the pharmaceutical industry or medical research
Or Master’s degree in Statistics/Biostatistics or related subject with high statistical content and at least 12 years of post-graduate statistical experience in the pharmaceutical industry or medical research

Job Responsibility

Utilizing knowledge and expertise to inform and provide sound statistical guidance to areas and teams in clinical development, reimbursement, and medical affairs.
Plan and execute statistical contributions to protocols, Flash Memos and Clinical Study Reports (CSRs)
Implement, manage and support standards, technical quality and consistent approaches in strategy, study design and statistical analysis.
Knowledgeable of developments in the field of statistics in drug development (innovative trial design) and Amgen’s statistical policies, procedures and strategies.
Understand, promote, and communicate innovative and standard statistical methodologies, trial design, data analysis, and medical / clinical understanding for product
Oversee statistical contributions to key design elements, protocols, randomization specifications, statistical analysis plans, tables, figures and listing shells, submission data file specifications, and other key study-related documentation
Collaborate cross-functionally to deliver robust, valid and scientifically rigorous analysis results in Table, Figure and Listings (TFLs), Flash Memos (FM), Clinical Study Reports (CSRs), clinical publications, and other communications
Serve as the GBS lead on the Clinical Study Team leadership team to execute clinical trials according to the protocol, performing risk assessments and ensuring quality data collection and alignment between data collection and study objectives
Contribute to clinical publications, regulatory filing documents, reimbursement documents and other communications for product or study
Provide statistical consultancy, training, and advice within Amgen

What we offer

Vast opportunities to learn and develop within our global organization
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Business Performance Senior Manager

The Business Performance Senior Manager is a member of the Transformation Execut...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Master’s degree (scientific area) and 10 years of directly related experience OR Bachelor’s degree (scientific area) and 12 years of directly related experience
Knowledge of Regulatory principles
Working with policies, procedures and SOP’s
Comprehensive understanding of regulatory activities and how they impact other projects and/or processes
General knowledge of national legislation and regulations relating to medicinal products
General awareness of the registration procedures/challenges in the region for CTAs, MAs and all lifecycle management activities
Knowledge and experience in the international regulatory environment relevant for product area and development stage
Understanding of drug development
Able to anticipate regulatory Agency questions and potential responses
Demonstrate strong teamwork ability

Job Responsibility

Represent GRAAS at cross-functional MAL and Business Development-related forums, providing strategic input and thought leadership
Form and lead sub-function teams for integration and licensing activities, ensuring alignment with strategic objectives
Drive strategic solutions to complex business problems, leading analyses and negotiations with key decision makers
Lead Regulatory workstreams across all deal phases
Serve as Lead for all product licensing work, including integrations into and transitions out of Amgen
Closely partner with Regulatory Affairs (RA) Therapeutic Area Integration Project Lead and advise/instruct them on end-to-end process and details of planning and execution of acquisition integration
Act as their delegate as needed in cross-functional meetings
Assist with pre-deal close GRAAS due diligence
Develop and manage GRAAS integration workplan
Draft and manage any new controlled documents unique to the integration, such as Quality Integration PLANs and bridging process GDEs

What we offer

Reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment

Senior Manager Global Category-Digital Health and Regulated Tech

We are seeking an individual who thrives in ambiguity, capable of driving catego...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Familiarity with procurement platforms such as Ariba, as well as ERP systems and advanced analytics tools
Excellent problem solving and organizational skills
Strong analytical skills, including the ability to analyze large datasets, identify trends, and derive actionable insights
Experience leading large, cross-functional teams and managing complex global projects in a matrixed environment
Strong knowledge of regulated software and digital health procurement
Familiarity with compliance frameworks (21 CFR Part 11, GxP, HIPAA, GDPR)
Experience with vendors in clinical technology, digital health, and connected medical solutions
Doctorate degree and 5 years of Global Strategic Sourcing, Procurement experience
Or Master’s degree and 12 years of Global Strategic Sourcing, Procurement experience
Or Bachelor’s degree and 15 years of Global Strategic Sourcing, Procurement experience

Job Responsibility

Lead category management for Digital Health and regulated technology software supporting clinical trials, patient engagement, and regulated applications
Partner with R&D, Clinical, Regulatory, and Compliance teams to ensure alignment with FDA, EMA, HIPAA, and GDPR standards
Negotiate contracts with vendors of e-clinical, ePRO, EDC, and patient-facing apps, balancing innovation with compliance
Build governance frameworks ensuring cybersecurity, data privacy, and quality system compliance for regulated digital solutions
Monitor evolving digital health regulations and integrate compliance into sourcing strategies
Provide strategic oversight as the lead for Digital Health and Regulated Software category and sourcing
Act as a trusted advisor to ensure that procurement initiatives are aligned with broader organizational objectives
Guide and facilitate collaboration across cross-functional teams and regional stakeholders
Ensure that all Software procurement activities are managed in compliance with regulatory, contractual, and operational risk requirements
Collaborate with Strategic Sourcing peers to oversee the strategic approach to complex negotiations for Software contracts

Senior Clinical Trial Manager

iconplc

Location:
Mexico , Mexico City

Category:
IT - Administration

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
January 07, 2026

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Senior Clinical Research Manager - Network Operations