Associate Director Study Start-Up Job at Amgen (Cambridge)

Associate Director Study Start-up

Drive world-class study start-up planning and execution across a global portfoli...

Location

United States

Salary:

182145.00 - 212860.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Pharma and clinical trial processes and operations expertise
Experience leading and managing global teams
Project management experience
Minimum of 3 years' experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources
Must meet one of the following education/experience combinations: Doctorate degree and 3 years of clinical execution experience
Master’s degree and 7 years of clinical execution experience
Bachelor’s degree and 9 years of clinical execution experience
Associate’s degree and 12 years of clinical execution experience
High school diploma / GED and 14 years of clinical execution experience

Job Responsibility

Lead and manage a team of Study Start-up Managers
Drive end-to-end study start-up planning and execution from global to local
Provide portfolio-level oversight of study start-up performance, resourcing, and delivery metrics
Build team capability through coaching, mentoring, performance management
Partner with functional and hub leaders to strengthen study start-up capabilities
Own and embed study start-up business processes
Foster a collaborative, high-engagement culture
Contribute to the evolution of the Study Start-up Hub model

What we offer

Total Rewards Plan comprising health and welfare plans for staff and eligible dependents
Financial plans with opportunities to save towards retirement or other goals
Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans and bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible

Fulltime

Associate Director / Director, Data Management

Reporting to the Senior Director, Clinical Data Management, the Associate Direct...

Location

United States , Cambridge

Salary:

185000.00 - 260000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

BS or MS degree in a scientific or health-related field
10+ years of experience in clinical data management within pharmaceutical/biotech and/or CRO environments
Demonstrated sponsor-side ownership of Phase I, II and III studies, from start-up through closure for multiple clinical studies
Strong hands-on experience with EDC systems (e.g., Medidata RAVE, Veeva EDC, Oracle Inform)
Deep knowledge of CDASH/CDISC, GCP/ICH, and FDA regulatory expectations
Proven experience overseeing CROs and external data vendors
Experience developing reports using J-Review and/or other CDM reporting tools
Prior IND, as well as NDA/BLA (filing/submission) experience, is highly desirable
Must be self-motivating, with strong analytical, organizational, and communication skills, with the ability to manage complexity across multiple studies
Demonstrated ability to navigate evolving priorities and drive timelines forward with focus and composure in a fast-moving organization

Job Responsibility

Lead sponsor side clinical data management activities across multiple concurrent studies within a defined therapeutic area
Own data management execution from study start-up through database lock and archival for concurrent studies, including late stage and registrational trials
Ensure data quality, integrity, and traceability to support interim analyses, CSRs, DSURs, IB updates, and program specific regulatory interactions
Proactively identify data risks, trends, and operational dependencies
Serve as the primary data management contact for CROs and third-party data vendors
Oversee outsourced CDM activities to ensure timely, high-quality deliverables aligned with sponsor’ expectations
Monitor CRO and vendor performance, escalating risks and proposing mitigation strategies
Contribute expert input to the development and evolution of data management standards, processes, tools/systems and vendor operating models
Provide hands-on leadership for CRF design and cross functional review, Edit check specifications and user acceptance testing, Data Management Plans and CRF Completion Guidelines, External data transfer specifications
Apply CDASH/CDISC expertise and partner with Statistical Programming to support SDTM readiness, validation outputs, Reviewer’s Guides, and define.xml

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

Trial Vendor Senior Manager

Parexel is currently registering interest for Trial Vendor Senior Manager to joi...

Location

United Kingdom

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Bachelor's degree or equivalent degree is required, with advanced degree preferred
3+ years working experience and excellent knowledge of the clinical operation processes and vendor management
Excellent knowledge of GxP and ICH regulations
Very good knowledge of clinical trial design and mapping to supplier requirements
Experience working with diverse cross-functional teams and a matrix environment and driving organizational excellence
Experience in User Acceptance testing for e-COA and IRT
Knowledge of key deliverables that impact green light milestones and vendor readiness
Experience or Expertise with Central Labs, Electronic Clinical Outcomes Assessment (eCOA), and Electronic Patient Reported Outcome (ePRO), Interactive Response Technology (IRT), Cardiac and Respiratory diagnostics, Patient Recruitment and Retention (PR&R), and/or Imaging reading (global process ownership, business system owner, SOP management, global training on supplier related SOPs and processes)
Very strong vendor management skills
outsourcing, contracting, and sourcing of clinical services

Job Responsibility

Interacts and collaborates closely with study team lead and study team members during study lifetime
Reviews vendor related protocol sections during protocol development
Collaborates with Vendor Study Manager (VSM) to the development of Study Specification Worksheet (SSW) to facilitate bid process
Manages interface with vendors in cooperation with vendor partner functions
Quote/proposal review in collaboration with procurement, support contract negotiations, if required
Contributes to the development of vendor contract amendments
Accountable for vendor cost control, budget review, invoice reconciliation and PO close-out
Manages vendor service excellence at study level, ensures vendors meet quality and service level standards in their service delivery for the trial
Covers all vendor activities after study start-up and all categories not covered by VSMs during start-up
Initiates/co-ordinates vendor kick-off meeting for categories not covered by VSMs

Associate Director, Regional Clinical Operations

Associate Director, Regional Clinical Operations. ICON plc is a world-leading he...

Location

United States , Atlanta; Houston; Tampa; Dallas

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Minimum Bachelor’s degree with 5-7 years of experience in Clinical Trial Operations in pharmaceutical / biotechnology industry or Clinical Research Organization, or equivalent, including at least 3 years in a role of primary responsibility for clinical trial execution and management
Thorough understanding and experience in global clinical trials in a diverse range of patient populations with preferred experience in both oncology and hematology
Direct management experience and supervisory responsibility
Demonstrated leadership and management skills
Goal oriented, self-starter with proven ability to work independently
Good knowledge and experience working with external specialist vendors
Excellent interpersonal, organizational, problem-solving, and written/verbal communication skills, confidence, and ability to work effectively with a wide variety of medical, research and administrative personnel
Able to proactively identify issues and provide potential solutions for resolution
Ability to manage multiple tasks simultaneously and meet deliverables in accordance with stated timelines and to established quality standards
Proficient in Outlook/Word/Excel/PowerPoint

Job Responsibility

Accountable for oversight of all assigned studies within the country in accordance with the overall development plan and clinical operations plan and under the direction of the global team (Global Clinical Trial Manager), including adherence to quality, timelines and budget
Accountable for planning and executing assigned country study goals and commitments, and as needed, leading, organizing, and participating in regional and/or local meetings and training sessions to implement country-level recruitment plans
Develops, builds and maintains optimal relationships with key institutions within the country (i.e. Site Alliance Sites), working closely with the Medical Science Liaisons, Global Site Management and Central Services, and other departments as indicated according to the Site Engagement Strategy
Drive the identification and inclusion of sites that have access to and can enroll patients who are from groups that have been historically underrepresented in clinical trials (per FDA Guidance for Industry for Improving Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials)
Oversees regional study feasibility, site monitoring performance, quality metrics and all relevant activities for assigned studies
Drives evidence-based site recommendations and selection
Provides support and training for sites to support diverse recruitment and retention, review, assist and optimize site-level diversity plans as needed, check and challenge progress and coordinate and align central efforts across sponsor and CROs
Align local and central initiatives and advise and guide on effective community engagement activities
Conduct co-monitoring and site identification visits, as needed
Collaborates cross-functionally to build and maintain strong relationships and interaction at the country local level (i.e. Medical Science Liaisons, Medical Monitors, Clinical Scientists, etc.) that directly contribute to key study activities and milestones

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

Associate Director Regional Clinical Operations

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

Location

United States , Boston, Philadelphia, PA

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Minimum Bachelor’s degree
5-7 years of experience in Clinical Trial Operations in pharmaceutical / biotechnology industry or Clinical Research Organization, or equivalent
At least 3 years in a role of primary responsibility for clinical trial execution and management
Thorough understanding and experience in global clinical trials in a diverse range of patient populations
Preferred experience in both oncology and hematology
Direct management experience and supervisory responsibility
Demonstrated leadership and management skills
Goal oriented, self-starter with proven ability to work independently
Good knowledge and experience working with external specialist vendors
Excellent interpersonal, organizational, problem-solving, and written/verbal communication skills

Job Responsibility

Accountable for oversight of all assigned studies within the country
Accountable for planning and executing assigned country study goals and commitments
Develops, builds and maintains optimal relationships with key institutions within the country
Drive the identification and inclusion of sites that have access to and can enroll patients from underrepresented groups
Oversees regional study feasibility, site monitoring performance, quality metrics
Provides support and training for sites to support diverse recruitment and retention
Conduct co-monitoring and site identification visits
Collaborates cross-functionally to build and maintain strong relationships
Communicates regularly on country study status and escalates unresolved issues
Collaborates with the Global Study Team to develop and execute risk management plans

What we offer

Competitive salary
Various annual leave entitlements
Range of health insurance offerings
Competitive retirement planning offerings
Global Employee Assistance Programme, LifeWorks
Life assurance
Flexible country-specific optional benefits

Fulltime

Director - Site Validation

At Amgen, our mission is to serve patients. At our Dun Laoghaire (ADL) site, we ...

Location

Ireland , Dun Laoghaire

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 4 years of directly relevant experience
Master’s degree and 8 years of directly related experience
Bachelor’s degree in Engineering, Life Sciences, or associated discipline and 10 years of directly related experience
Within experience must have 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, and programs or directing the allocation of resources
Extensive experience in validation within a sterile/aseptic manufacturing environment (fill-finish highly preferred)
Strong expertise in: Aseptic process simulation (media fills)
Cleaning validation
Equipment qualification and lifecycle management
Commissioning and qualification (CQV) for capital projects
Proven experience supporting large-scale capital project delivery and facility start-ups

Job Responsibility

Strategic leadership for all site validation activities, ensuring alignment with Amgen global standards, regulatory requirements, and site objectives
Leading and developing a high-performing Validation organisation, setting clear expectations and fostering a culture of quality, compliance, accountability, and continuous improvement
Development of the organisation includes robust succession planning as well as a focus on how the function will support 24/7 operations e.g. via a new validation shift team
Owning all validation lifecycle activities including: Aseptic Process Simulations (media fills) strategy and execution
Airflow Visualisation Studies (AVS) and HVAC requalification programs
Sterilisation validation (VHP, autoclaves, SIP/CIP, lyophilisation)
Cleaning validation programs
Equipment validation
Facilities and Utilities
Effective continued process verification and lifecycle validation, including periodic review, requalification and data-driven performance monitoring programs

What we offer

Vast opportunities to learn and move up and across our global organisation
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan — including health, finance, and wealth benefits
Flexible work models, including remote and hybrid work arrangements, where possible

Fulltime

New

Senior Lecturer/Associate Professor in Literacy

As a Senior Lecturer / Associate Professor in Literacy, you will play a key role...

Location

Australia , Albury-Wodonga, Bathurst, Port Macquarie, Wagga Wagga

Salary:

Not provided

Charles Sturt University

Expiration Date

June 08, 2026

Requirements

A doctoral qualification relevant to literacy or education, with a recognised teaching qualification
A strong record of high-quality teaching and student-centred learning
An established or emerging research profile aligned to literacy, curriculum or pedagogy
The ability to build productive partnerships and contribute to academic leadership

Job Responsibility

Lead impactful literacy teaching and research
Teach across online and on-campus environments
Shape future teachers and education practice
Contribute to curriculum innovation
Build strong relationships with students and partners
Provide academic leadership in literacy education
Contribute to the School's research profile
Supervise higher degree research students
Actively engage with professional, community and government stakeholders
At Associate Professor level: significant academic leadership, research impact, and contribution to the broader discipline at national/international level

What we offer

17% superannuation

Fulltime

Select Country

Associate Director Study Start-Up

Amgen

Location:
United Kingdom , Cambridge ▼
London
Uxbridge

Category:
-

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
February 18, 2026

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