Clinical Study Manager Job at Proclinical (Stockholm)

Manager, Clinical Vendor Management

The Manager, Clinical Vendor Management is a member of the Clinical Trial Excell...

Location

United States

Salary:

150000.00 - 160000.00 USD / Year

Apogee Therapeutics

Expiration Date

Until further notice

Requirements

Knowledge of the drug development process in complex indications for large global programs
Strong understanding of contracting process and ability to negotiate and manage contractual arrangements
Ability to prepare bids, requests for quotes, and proposals
Excellent communication skills with an ability to present to a variety of stakeholders and tailor messages accordingly
Proven ability to influence and make decisions in a matrixed environment
Comfortable leading candid conversations on vendor delivery and driving to resolution of performance challenges
Partnering with study teams and vendors to effectively manage conflicting viewpoints and challenging situations with minimal negative impact
Experience in problem solving capabilities
can see a problem from multiple angles and provide viable, innovative options for resolution
Demonstrated ability to effectively manage priorities to achieve goals and support unplanned work

Job Responsibility

Collaborate with business partners to research and evaluate potential vendors based on their capabilities, pricing, and service level agreements
Build strong relationships with key vendors
Conduct ongoing assessment of vendor relationship performance through KPI review, vendor performance trend analysis, and administration/interpretation of stakeholder satisfaction surveys
Drive and improve existing systems and processes
Maintain knowledge of market trends for assigned key vendors
Lead and conduct high visibility and competitive negotiations
Support sourcing policies, contingency plans, and additional strategic initiatives established by the Vendor Strategy & Management Lead
Support Clinical Operations Vendor Sourcing and vendor governance related meetings
Hold vendors accountable to performance goals/agreements
Drive annual third-party vendor spend savings while improving processes and vendor relationships

What we offer

Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
Three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave
Commitment to growing you professionally and providing access to resources to further your development
Apogee offers regular all team, in-person meetings to build relationships and problem solve

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

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

Clinical Trial Manager

Beam is seeking an experienced and motivated Clinical Trial Manager (CTM) to joi...

Location

United States , Cambridge

Salary:

125000.00 - 155000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

Bachelor's Degree in life sciences or related field with 8+ years' experience in biotech and/or pharmaceutical industries managing clinical trials
Phase I experience is strongly preferred
a background in rare disease and/or metabolic disorders is highly desirable
experience with cell & gene therapy is a plus
Experience with GCP/ICH Guidelines, and a strong understanding of cross-functional clinical processes
Exceptional organizational skills and ability to deal with competing priorities
strong reasoning and problem solving ability
Ability and willingness to travel up to 20% (domestic and international)

Job Responsibility

Manage all project team activities related study start up, conduct and close out activities
Work with Outsourcing and Contracts Management to ensure Site Contracts reflect trial activities and related budget
Manage Change Orders with Sites (and Vendors when necessary)
Contribute to development of Informed Consent Form and provide oversight and approval for all country and site level ICF
Oversee preparation and submission of essential documents to IRBs/ECs and regulatory authorities
Contribute to (or oversee the management of) the creation of the trial plans and site facing documents
Develop (or overseeing the development of) all training/day to day materials
Support data management activities
Monitor (and escalate appropriately) vendor metrics and vendor performance
Organize, oversee and/or participate in all study related meetings

Fulltime

Country Study Operations Manager

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

Location

South Korea , Seoul

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

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

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

Senior Study Specialist, Global Study Operations

The Sr. Study Specialist (SS) significantly contributes to or leads tasks relate...

Location

United Kingdom , London

Salary:

Not provided

BioMarin Pharmaceutical

Expiration Date

Until further notice

Requirements

BA/BS or higher in nursing, life or health sciences is preferred
Industry or relevant experience in lieu of education is considered
Experience in a biotechnology or pharmaceutical company
Experience in oversight of external vendors including SOW, budgets, POs, and invoice management (e.g., CROs, central labs, imaging etc.)
Proficient knowledge and experience in Agility and Proactivity, Leadership, Communication and Collaboration, Study Management and Execution, Compliance and Quality, Drug Development and Study Design, Product and Therapeutic Area Knowledge

Job Responsibility

Develop study specific documentation, as delegated by the Study Manager
Contribute to the oversight of country and site feasibility assessment and site selection
Oversight of CRO for IRB/EC related submission/approval activities
Oversight of essential documents for study life-cycle management
Develop/Oversee site and investigator training materials
Present at investigator meetings as assigned
Ensure accurate and timely study entry and updates to ClinicalTrials.gov
Facilitate Screening Authorization Forms sign off and oversee tracking, where applicable
Process documents for signature in DocuSign
Oversight of Clinical Trial Insurance

Clinical Project Manager

Permanent position available immediately located in Paris. The role involves lea...

Location

France , Paris

Salary:

Not provided

AB SCIENCE

Expiration Date

Until further notice

Requirements

Holder of additional training in methodology (CESAM, IUD, …)
Successful experience of Clinical Project Manager in a pharmaceutical company or CRO
6-8 year’s experience in clinical development (Phase II and III)
Experience in oncology or autoimmune inflammatory diseases would be a plus
Experience in international development required
Experience of the regulatory environment for clinical trials
Experience of writing research reports and FDA regulatory dossiers (IND, NDA) and EMA
Fluent in English

Job Responsibility

Design, implementation and coordination of clinical studies with the support of Clinical Operations, Pharmacovigilance, Biometrics and Medical Writing
Plan the clinical development program
Prepare studies protocols, amendments and reports
Prepare regulatory dossiers
Manage relationships with investigators and opinion leaders

What we offer

Salary and package to define according to skills and experience

Fulltime

Clinical Study Manager

Proclinical

Location:
Sweden , Stockholm

Category:
Research and Development

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
February 19, 2026

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Job Responsibility:

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Job Posted:
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