Trial Delivery Lead Job at iconplc (Blue Bell)

Trial Delivery Management (Base)

As a TDM at ICON, you will be responsible for leading and coordinate project act...

Location

United States , Blue Bell

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor's degree in project management, business, or a related field is preferred, with significant experience in project management and team leadership
Proven track record of successfully managing projects from inception to completion, with a focus on delivering results within scope, time, and budget constraints
Strong leadership and organizational skills, with the ability to effectively manage project teams and prioritize tasks
Excellent communication and interpersonal skills, with the ability to build relationships and manage stakeholder expectations
Proficiency in project management tools and methodologies, with certifications such as PMP or PRINCE2 being advantageous
Detail-oriented, proactive, and adaptable, with a commitment to achieving project goals and driving continuous improvement
Willingness to travel as required (approximately 30%)

Job Responsibility

Developing and managing detailed project plans, including timelines, budgets, and resource allocation to ensure successful project delivery
Leading cross-functional project teams, coordinating efforts to meet project objectives, and facilitating effective communication and collaboration
Monitoring project progress, identifying potential risks and issues, and implementing strategies to address challenges and keep projects on track
Engaging with stakeholders to manage expectations, provide updates, and ensure alignment with project goals and organizational objectives
Preparing and presenting project reports, status updates, and performance metrics to senior management and other stakeholders

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

Trial Delivery Management (Base) - Immunology

As a Trial Delivery Management (Base) at ICON, you will be responsible for leadi...

Location

United States , Blue Bell

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor's degree in project management, business, or a related field is preferred, with significant experience in project management and team leadership
Proven track record of successfully managing projects from inception to completion, with a focus on delivering results within scope, time, and budget constraints
Strong leadership and organizational skills, with the ability to effectively manage project teams and prioritize tasks
Excellent communication and interpersonal skills, with the ability to build relationships and manage stakeholder expectations
Proficiency in project management tools and methodologies, with certifications such as PMP or PRINCE2 being advantageous
Detail-oriented, proactive, and adaptable, with a commitment to achieving project goals and driving continuous improvement
Willingness to travel as required (approximately 30%)

Job Responsibility

Developing and managing detailed project plans, including timelines, budgets, and resource allocation to ensure successful project delivery
Leading cross-functional project teams, coordinating efforts to meet project objectives, and facilitating effective communication and collaboration
Monitoring project progress, identifying potential risks and issues, and implementing strategies to address challenges and keep projects on track
Engaging with stakeholders to manage expectations, provide updates, and ensure alignment with project goals and organizational objectives
Preparing and presenting project reports, status updates, and performance metrics to senior management and other stakeholders

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

Trial Delivery Management-Advanced

Trial Delivery Management (Advanced) - Oncology. ICON plc is a world-leading hea...

Location

United States , Burlington; Blue Bell

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor's degree in a relevant scientific discipline or healthcare-related field
Extensive experience in project management, with a proven track record of leading successful projects in the pharmaceutical or biotech industry
Strong proficiency in project management tools and methodologies, with excellent attention to detail
Excellent analytical and problem-solving skills, with the ability to develop effective project strategies
Demonstrated leadership skills, with experience in managing and mentoring teams effectively
Exceptional communication skills, with the ability to convey technical concepts to diverse audiences
Detail-oriented, with strong organizational skills to manage multiple projects and deadlines in a dynamic environment
Willingness to travel as required (approximately 25%)

Job Responsibility

Managing day-to-day trial and program management activities
Developing and executing project plans, focusing on achieving project goals and objectives
Leading cross-functional teams to ensure the successful implementation of project activities
Collaborating with stakeholders to identify project requirements and define project scope
Mentoring and guiding team members, fostering a culture of excellence and continuous improvement
Driving the development of project documentation and reports to present findings to stakeholders in a clear and actionable manner
Staying abreast of industry trends and emerging technologies to integrate best practices into project management strategies
Contributing to organizational growth through effective project leadership and strategic planning

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

Data Delivery Lead

Join Amgen’s Mission of Serving Patients. At Amgen, if you feel like you’re part...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

8-15 years’ work experience in life sciences or medically related field, including 5 years of biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company
Experience engaging and working across clinical trial teams in multiple geographies to deliver global clinical trials
Experience in management and oversight of external vendors (e.g., CROs, central labs, imaging vendors, etc.)

Job Responsibility

Serve as the single accountable leader for study-level data management, driving quality, delivery, and cross-functional alignment, locally and globally
Lead development and execution of the Data Management Plan and Integrated Data Review Plan (IDRP) aligned to protocol and program strategy
Drive database build, UAT, and go-live readiness in partnership with Database Design and Acquisition teams
Oversee study conduct activities including data cleaning, query management, reconciliation, and database lock preparation, ensuring we are ‘delivery ready’ at all times
Monitor study data metrics (e.g., eCRF entry, Non-CRF data collection, query aging, reconciliation backlog, KRIs) and proactively resolve issues to ensure on-time delivery
Lead data deliverables, proactive in follow up, ensuring issue resolution and high-quality outputs

What we offer

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

Diagnostic Delivery Lead

The Diagnostic (Dx) Delivery Team within Oncology Translational Medicine (OTM) i...

Location

United States; United Kingdom , Collegeville, Pennsylvania; Stevenage; Waltham, Massachusetts

Salary:

151500.00 - 252500.00 USD / Year

GSK

Expiration Date

Until further notice

Requirements

Bachelor’s degree in biological sciences or related discipline
7+ years of industry experience
Experience in clinical trial specimen management
Experience overseeing third‑party vendors and laboratories, including contracting activities
Professional experience within the Oncology therapeutic area
Experience with diagnostic assay development and validation

Job Responsibility

Drives the implementation of clinical diagnostic plans for therapeutic programs in early and late stage clinical development across Oncology, ensuring audit readiness
Accountable for the development of the clinical study’s diagnostics biosample collection, processing and storage strategies and ensuring their logistical feasibility and cost effectiveness
Accountable for planning and implementing the diagnostic biosample collection within a clinical study including definition of the appropriate material, instructions, lab manual development & review, kit development, database set up, etc.
Accountable for forecasting and planning of biosample analysis and sample management costs within projects or clinical studies
Contributes to study protocols and ICFs prior to finalization and provides input to ensure the protocol and ICFs enable sample testing according to the diagnostic plan
Work with Clinical Operations to draft Site Communications and Training Materials
train CRO and internal teams on sample collection/processing activities as required
Project manages the implementation of clinical trial assays at reference labs and centralized testing vendors, ensures delivery of assay/data results and is a key contact for the assay lab
Ensures alignment of outputs with the requirements of Data Management and Biostatistics, and provide expert input into data transfer agreements
Serves as first point of contact for diagnostic biosample operational questions and issues within a project and coordinates with internal and external partners (e.g., Laboratory Study Management, Clinical Operations, Diagnostic Leads, and CROs)

What we offer

Competitive base salary
Annual bonus based on company performance
Flexible working options available for most roles
Learning and career development
Access to healthcare & wellbeing programmes
Employee recognition programmes
Eligibility to participate in our share based long term incentive program
Health care and other insurance benefits (for employee and family)
Retirement benefits
Paid holidays

Fulltime

Local Delivery Lead

Provides leadership, oversight and manages the activities of within-country oper...

Location

Canada , Mississauga

Salary:

121000.00 - 171000.00 CAD / Year

GSK

Expiration Date

Until further notice

Requirements

Bachelors degree or equivalent. Any general science degree e.g. life science, medicine, clinical research, pharmacy etc.
Broad experience in clinical development or equivalent experience in the pharmaceutical or health-related field. A minimum of 3 years of clinical research experience within GSK or externally.
Excellent matrix leadership skills, promoting motivation and empowerment of others in order to accomplish individual, team and organisational objectives.
Solid operational knowledge of clinical research with experience in all stages of study lifecycle (start-up, recruitment and close out) and understanding of R&D and drug/vaccine development process.
Effective at problem solving, negotiation and conflict resolution skills in a matrix environment
Stakeholder management skills required as the role includes interactions with external clinical site staff and senior stakeholders at a central or local level.
Strong written and verbal communications skills are required in English and local language of the countr(ies).
Strong planning and organizational skills, with the ability to work efficiently and effectively in a dynamic environment. Works in an environment that is constantly evolving with new processes and systems, internally and externally and adapts to these changes quickly and efficiently.
Demonstrates track record in quality decision-making and problem resolution. Able to set and manage priorities, resource and performance targets of local study deliverables. Recognizes potential risks and can implement effective mitigation strategies.
Recognizes and reacts to changes that impact a study and/or program or practices, and has the skill set to assess the appropriateness of protocol/plans in the local environment.

Job Responsibility

Leads the local study team consisting of within-country clinical operations team members, cross-functional experts (medical, regulatory, supply logistics, finance, legal, etc.), vendor staff and external clinical site staff involved in study preparation and delivery
providing both matrix leadership and project mangement of study activities within the countr(ies).
Serves as the operational point-of-contact between the central GSK study team and within-country study team. The LDL collaborates closely with local medical and regulatory affairs staff to align on local medical and scientific requirements. As required, collaborates with the local and above-country teams for conducting study feasibility and site selection within countr(ies).
Accountable for within-country delivery of assigned studies to time, budget and quality expectations as defined in the clinical development plan and study protocol as well as in local regulations, IND/GCP/ICH-guidelines, GSK Corporate, Vaccines, and local SOPs and POLs.
Ensures that critical study timelines related to study activities within-countr(ies) are accurately forecasted and achieved and that recruitment targets, patient recruitment cycle times, data and audit quality are met. Provides trouble-shooting and problem resolution support for within-country study team to ensure productive, efficient study delivery.
Accountable for the accuracy of study systems, including completeness of the trial master file, and reporting study delivery progress to study team and key stakeholders.
Identifies and resolves or escalate risks and issues that may impact study delivery.
Provides feedback on performance, capabilities and competencies of study members to line management. As required, will review and approve monitoring visit reports and ensure appropriate site monitoring activities have been completed per the study monitoring plan.
Has the accountability to estimate, track and deliver against the local budget for the studies within their scope of responsibility.
As required, advises on contract development with Sites/CRO/Vendors and may participate in budget/contract negotiations with study vendors or clinical investigator sites.

What we offer

Competitive base salary
Annual bonus based on company performance
Flexible working options available for most roles
Learning and career development
Access to healthcare & wellbeing programmes
Employee recognition programmes

Fulltime

Director Medical Data Review

At Amgen, if you feel like you’re part of something bigger, it’s because you are...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Master/ Doctorate/ MD with ~ 18 years of Industrial experience
9+ years of experience in life sciences or a medically related field, including significant experience in medical monitoring and/or clinical data review
Prior people management experience with direct reports
Demonstrated strategic leadership of a clinical data review or medical monitoring function
Experience leading clinical trial process improvement and data quality optimization initiatives
Strong communication and presentation skills (written and oral)
Deep understanding of operational aspects of clinical data review
Advanced proficiency with clinical data analysis tools (e.g., Spotfire or equivalent)

Job Responsibility

Define and execute the enterprise-wide vision, strategy, and multi-year roadmap for Medical Data Review (MDR), including operating model, technology enablement, workforce capabilities, and organizational transformation
Lead enterprise transformation initiatives that advance risk-based and technology-enabled clinical oversight, including AI-assisted review, automation, RBQM integration, integrated data review, and predictive risk management
Establish and govern enterprise standards, KPIs, quality benchmarks, and risk thresholds to ensure consistent, high-quality medical data review across the clinical development portfolio
Partner with senior leaders across Therapeutic Areas, Clinical Operations, Data Management, Safety, and Digital functions to drive strategic alignment and resolve enterprise-level trade-offs involving quality, timelines, cost, and risk
Establish and lead governance frameworks that provide oversight of clinical data review strategy, quality performance, risk management, and continuous improvement across the organization
Provide strategic leadership for the global MDR organization, including organizational design, resource planning, capability development, and scalable operating models that support diverse clinical programs
Drive operational excellence and trial delivery predictability through proactive performance management, data-driven decision-making, and standardized yet flexible review frameworks
Evaluate emerging industry trends and translate innovations into practical enterprise capabilities that improve quality, efficiency, and risk management
Own the enterprise inspection readiness strategy for clinical data quality, ensuring robust review traceability, regulatory compliance, proactive risk mitigation, and executive-level issue escalation
Champion innovation through the adoption and scaling of advanced analytics, AI/ML-enabled capabilities, predictive risk modeling, and integrated review technologies that transform insights into business outcomes

Fulltime

Senior Business Development Executive (BDE)

As Senior BDE, you'll own the full sales cycle for our software development serv...

Location

India , Ahmedabad

Salary:

Not provided

SolGuruz

Expiration Date

Until further notice

Requirements

Minimum 6 years of experience selling software development / IT services, with proven success in web, mobile, and AI/ML development services
Demonstrated track record of closing high-value international deals and consistently hitting revenue targets
Proven people-management experience — leading and mentoring a sales team
Strong commercial acumen: able to scope, price, and negotiate complex service engagements
Excellent English communication, presentation, and stakeholder-management skills
Comfortable holding credible conversations with both technical (CTO/architect) and business (founder/CXO) audiences
Hands-on with CRM tools and a structured, data-driven approach to pipeline
Experience with international business travel and representing a company at global events, conferences, or expos

Job Responsibility

Own the end-to-end sales cycle for software development services across web, mobile, and AI/ML from lead generation and discovery to proposal, negotiation, and close
Build and manage a healthy pipeline across international markets (USA, North America, Europe, Australia, Middle East)
Sell our engagement models with confidence Fixed Price, Dedicated Team, Hourly/Agile, and Maintenance & Support and recommend the right fit per client
Lead discovery and solution conversations with founders, CTOs, product heads, and procurement teams
Position our 1-week risk-free trial as a deal-accelerator and de-risking tool
Prepare and present proposals, SOWs, and commercial terms
negotiate scope and pricing to protect margin while winning the deal
Consistently meet and exceed monthly, quarterly, and annual revenue targets
Represent SolGuruz at international conferences, trade shows, expos, and networking events
Plan and execute event-led pipeline generation pre-event outreach, on-ground meetings, and structured post-event follow-up

Fulltime

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Trial Delivery Lead

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