Biotech Project Leadership - Clinical Trials Job at Parexel

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

Associate Vice President, Clinical Data Management

The Associate Vice President, Clinical Data Management is a member of the Global...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Bachelor’s or master’s degree with 25+ years of data management experience
10 to 15 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
Experience within clinical data management, regulatory compliance, and strategic leadership within a pharmaceutical, biotech, or CRO environment
Expertise in GCP, ICH, FDA, EMA regulations, data governance, and clinical trial data standards (CDISC, SDTM)
Experience within cross-functional collaborations, leadership, and strategic planning skills, ensuring operational excellence and compliance while driving innovation in data management to support Amgen’s global clinical development efforts
Expertise in AI/ML-driven data management solutions, automation, and advanced analytics
Understanding of clinical data standards (CDISC, SDTM, ADaM)
Experience leading regulatory submissions, including NDA/BLA/MAA filings and advisory committee interactions
Proven ability to drive organizational change, optimize processes, and implement lean principles in clinical data management
Cross-functional collaboration experience with clinical operations, regulatory affairs, biostatistics, and R&D teams

Job Responsibility

Develop and drive the global data management strategy in alignment with clinical development objectives and corporate goals
Provide strategic and operational leadership to the Clinical Data Management (CDM) function across all clinical programs and phases
Lead innovation initiatives, including the implementation of development integration programs and the adoption of cutting-edge technologies to enhance data workflows
Represent Clinical Data Management in executive leadership discussions, regulatory interactions, and industry forums
Establish and enforce robust clinical data governance models, policies, and risk mitigation strategies to ensure quality and compliance
Make final decisions regarding standard operating procedures (SOPs), CDM best practices, and process optimization
Engage key stakeholders and ensure timely resolution on critical data integrity and regulatory compliance issues
Serve as the primary CDM representative during regulatory inspections and audits, with responsibility for final decisions on findings, responses, and corrective actions
Influence cross-functional clinical development, operational, and regulatory strategies through data-driven insights and analytics
Partner closely with Clinical Program Operations, Regulatory, Biostatistics, and R&D to ensure seamless integration and alignment of clinical data

New

Project leader

As a part of the global Project Leadership group at Parexel, you are responsible...

Location

United States , Remote

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Undergraduate degree in a clinical or health related field (advanced degree preferred)
Minimum 2+ years' experience leading Global Clinical Trials in Project Management within a CRO (preferred), Biotech or Pharma company
Experience in project scheduling, managing resources and budgets and coordinating team activities
Experience with the full clinical development process through regulatory submissions
Additional years of experience required for more senior roles
Flexibility, problem solving capabilities and strategic vision
Detailed-oriented, computer proficient and possess superior interpersonal and organizational skills

Job Responsibility

Lead cross-functional teams to deliver high-quality and patient-focused clinical trials
Collaborate with clients and internal stakeholders to identify project requirements, develop project plans, and manage project timelines and budgets
Provide leadership to project teams and manage the day-to-day operations
Achieve operational excellence through on time delivery within budget and to the highest quality

What we offer

Supportive work environment
High degree of empowerment and accountability
Work with a diverse set of clients and therapeutic areas
Encouraged to take on new challenges and pursue your interests
Flexible work arrangements (remote, in-office and hybrid roles)
Career progression opportunities

New

Director of Quality Assurance, Clinical

Responsible for leading in the development, implementation and maintenance of QA...

Location

United States , Berkeley

Salary:

220000.00 - 235000.00 USD / Year

Caribou Biosciences

Expiration Date

Until further notice

Requirements

Undergraduate or graduate degree(s) in Biological Sciences, Chemistry, or related Science discipline
At least 15 years of experience in clinical quality assurance (GCP, GLP and PV) in cell & gene therapy/biotechnology and/or pharmaceutical industry
Experience working in biologics is strongly preferred
Subject Matter Expert (SME) working knowledge on current interpretation/implementation of United States Code of Federal Regulations, ICH Guidelines and other local government regulatory requirements governing clinical research
Proven track record in developing and implementing quality systems and processes in a clinical setting
Expertise in creating and executing audit plans outlining all service providers (vendor) audits, clinical investigator site audits, CSV audits and process audits
Advanced knowledge of Quality Assurance principles, concepts, industry practices, and standards
Prior GLP experience with quality oversight and auditing studies/vendors (preferred)
Excellent verbal and written communication skills
Ability to lead cross-functional teams and independently prioritize work

Job Responsibility

Compliance Oversight: Ensure that all clinical trial activities comply with guidelines and international regulations (e.g., ICH-GCP and ICH-PV), and applicable laws
Documentation Review: Conduct thorough reviews of study-related documentation, including protocols, investigator brochures, informed consent forms, and CSRs, to verify compliance with GCP requirements
Provide Clinical Quality Assurance (GCP) strategic and technical leadership and Subject Matter Expertise (SME) to clinical study teams
Partner with the teams to effect appropriate and timely documentation of quality event management, including CAPA plans in support of product pipeline
Plan and oversee activities in support of regulatory submissions and inspections
Lead GCP Inspection Readiness efforts, ensure implementation and prepare internal and external teams for Pre-Approval Inspections (PAI)
Implement, monitor, and promote best practices of all Quality Assurance Systems to ensure compliance with relevant FDA, EU and ROW regulations/directives/requirements and ICH guidelines
Quality Management System (QMS): Maintain and enhance Caribou’s QMS by implementing processes and procedures that ensure consistent adherence to GCP, GLP and PV standards throughout the clinical trial lifecycle
Develop and implement the appropriate suite of Standard Operating Procedures (SOPs), quality manuals, policies, and other related quality documents
Ensure that these systems are effectively communicated, understood, and followed by relevant stakeholders

What we offer

Comprehensive compensation package, which includes competitive salary, bonus, and equity for all employees
Generous paid vacation time, in addition to company-observed holidays
Excellent medical, dental, and vision insurance
401(k) retirement savings plan, which includes matching employer contributions
Employee stock purchase plan (ESPP)
Tuition reimbursement program

Fulltime

Global Procurement Senior Director - Development Business Partner Lead

In this vital role you will serve as the Business Partner Lead for Global Develo...

Location

United States

Salary:

219569.00 - 254532.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 5 years of procurement, category management, research and development, or related experience
Master’s degree and 9 years of procurement, category management, research and development, or related experience
Bachelor’s degree and 11 years of procurement, category management, research and development, or related experience
At least 5 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources

Job Responsibility

Serve as a trusted advisor and thought leader within the Global Development organization, offering expert insights into market trends, supplier capabilities, and best practices for R&D strategies
Forge strategic, high-impact partnerships with key partners across Global Development, ensuring alignment between business priorities and Category strategies
Leverage market intelligence to craft business strategies that seamlessly connect with Development category objectives
Work strategically with the supply base to drive supplier-enabled innovation that supports and enhances business partner objectives
Provide R&D Procurement expertise to catalyze business development, operational innovation, and other high-value initiatives
Collaborate with Finance and cross-functional teams to generate, capture, and recognize value across the Clinical Trial pipeline. Influence budgetary decisions and profit-and-loss outcomes to increase impact
Promote the adoption of Procurement-led and business-aligned critical initiatives, ensuring integration across stakeholders, end users, suppliers, and strategic partners
Bridge the gap between procurement performance and business objectives by driving the implementation of relevant initiatives developed by Category Leads

What we offer

A 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
Flexible work models, including remote and hybrid work arrangements, where possible

Fulltime

New

Technical Project Systems Engineer

Location

United States , New York

Salary:

125085.00 USD / Year

Dalet

Expiration Date

Until further notice

Requirements

Master’s degree in Information Systems, Computer Science or Electronics and Computer Engineering and two (2) years of experience in job offered or two (2) years of digital project coordination focusing on network engineering/administration

Job Responsibility

Help direct the implementation, maintenance and configuration of company’s software systems and network requirements for the specific needs of multinational organization’s individualized broadcast and Media Asset Management (MAM) clients
Evaluate software and network requirements, provide workflow analysis, specify interfaces, oversee technical integrations, define implementation plans, and test and document advanced integrations with company and third-party software, especially related to substantial product changes or customizations
Develop and integrate the implementation process and coordinate the efforts of the developmental, testing, and validation groups with company’s internal installation technicians
Communicate with global organizational R&D teams to ensure projects workflows and defects are well understood and report internally on the progress of project delivery to senior executives
Investigate and report technical issues and define and implement workaround solutions
Deploy and test systems and network fixes provided directly by Dalet R&D and maintain a full set of professional technical documentation (Installation Worksheets, Configuration Plans, etc.) to help ensure projects are within estimated and pre-budgeted timing and cost constraints
Assist company’s Solution Architects regarding the solution design and system specifications sessions with individualized customers
Write and execute unique and individualized test scripts for clients and contribute proactively to continuous systems and network process improvements
Develop and elaborate on strategic project plans, UAT documents and other typical deliverables as required

Fulltime

New

Sr. Mobile (Flutter) Engineer

Hybrid Work / WFH Available; Impactful Product for Global Sales; Comprehensive G...

Location

Japan , Tokyo

Salary:

6000000.00 - 10000000.00 JPY / Year

Randstad

Expiration Date

December 17, 2026

Requirements

3+ years of experience in mobile app development
Expertise in Flutter or native (Swift/Kotlin) languages
Full development cycle experience (design to deployment)
Professional level English proficiency

What we offer

健康保険
厚生年金保険
雇用保険
土曜日
日曜日
祝日

Fulltime

New

Network Project Administrator

Network Project Administrator for company in the digital media asset management,...

Location

United States , New York

Salary:

105000.00 USD / Year

Dalet

Expiration Date

Until further notice

Requirements

Master’s degree in Computer Science, Network Engineering, or Information Technology
one (1) year of experience in job offered or one (1) year of network and/or software administration/engineering experience

Job Responsibility

Evaluate network requirements, provide workflow analysis, specify interfaces, perform technical network integrations, define network implementation plans, and act responsible for testing and systems monitoring
Detail and document the specific technical requirements needed to integrate company products into customer sites
Perform system administration and technical documentation functions detailing the network and software configurations and interface with all on-site systems
Investigate and report technical network and software issues and define and implement workaround solutions
Write and execute test scripts, as well as test, validate and troubleshoot networks and software
Deploy, configure, test (UATs) and launch support of projects using Java and Groovy programming, network, server administration, cloud management services and MariaDB and PostgreSQL database knowledge and experience
Contribute to the design and execution of rigorous testing protocols in collaboration with client consultants

Fulltime

Biotech Project Leadership - Clinical Trials

Parexel

Location:
United States

Category:
Research and Development

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
January 04, 2026

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