Clinical Trial Manager at Bristol-Myers Squibb

Madrid, Community of Madrid, Spain

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Biotechnology, Clinical ResearchIndustries

Requirements

Acts as the primary point of contact at a country level for internal and external stakeholders
Ensures adherence to timelines, budget, and quality standards for end-to-end study operational oversight and delivery

Responsibilities

Acts as the main point of contact for a country with global study team members and accountable for the coordination with local country cross functional teams
Implements the local country and site feasibility process, including proposal and validation of country study targets, as endorsed by country leadership
Plans, develops and executes timelines and activities for start-up in collaboration with the local study team, Global Trial Acceleration Centre (GTAC) and other relevant stakeholders
Implements country and site level patient recruitment strategy and risk mitigation
Coordinates and ensures country level study enrolment targets and timelines are met in collaboration with relevant stakeholders
Leads problem solving and resolution efforts including management of risk, contingencies, issue resolution and escalation to the appropriate stakeholder/s
Assesses and sets up vendors during study start up period (locally)
Participates in and prepares for Investigator Meetings
Ensures data entered in the Clinical Trial Management System (CTMS) is current and complete, and access to eDC and vendor systems is available for the country and clinical trial site personnel, including entering necessary data and uploading documents in eTMF
Validates study related materials (i.e. protocol, ICF, patient material)
Supports the review of country and site-specific documents (e.g. ICF, patient material), and where applicable may include the preparation of site level ICF and other documents
May support preparation of materials for Site Initiation Visits
Verifies and confirms with local team eTMF completeness (Country and Site level)
Prepares investigator sites to conduct clinical trials through verifying acceptability of Clinical Trial Package (CTP) documentation
Acknowledges Site Monitoring visit reports, takes action within the timelines specified and escalates issues and ensures appropriate documentation of issues
Coordinates database locks and query follow up, ensuring timelines are met
Ensures inspection readiness of assigned trials within country and provides support to Health Authority inspection and pre-inspection activities
Coordinates and completes the Corrective Actions / Preventive Actions (CAPA) and ensures implementation for Country audit level findings; drives CAPA review, implementation and completion
Coordinates study team meetings locally
Supports GTAC in the resolution of queries related to site invoices and supports in the coordination of patient compensation claims (if applicable)
Collaborates with the local study team to support the management of site relationships

Skills

Clinical Trial Management

Study Oversight

Feasibility Assessment

Patient Recruitment

Risk Mitigation

Stakeholder Coordination

Timeline Management

Budget Management

Cross-Functional Coordination

Project Execution

Bristol-Myers Squibb

Develops and delivers biopharmaceutical medicines

About Bristol-Myers Squibb

Bristol Myers Squibb (BMS) develops and delivers medicines aimed at treating serious diseases, focusing on areas like cancer, autoimmune diseases, and heart conditions. The company conducts extensive research and development to create new drugs, which are sold after receiving regulatory approval. BMS also produces generic drugs, offering affordable alternatives that meet the same quality standards as their branded counterparts. What sets BMS apart from competitors is its dual focus on both innovative and generic medicines, enhancing access to healthcare. The company's goal is to improve patient outcomes while maintaining a commitment to sustainability and corporate responsibility.

New York City, New YorkHeadquarters

1887Year Founded

$33,706.1MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Flexible Work Hours

Hybrid Work Options

Professional Development Budget

Risks

Increased competition in oncology from emerging biotech firms like ArsenalBio.

BMS's lawsuit over the 340B Drug Pricing Program may lead to regulatory challenges.

Rapid AI and digital tech evolution may pose integration challenges for BMS.

Differentiation

BMS focuses on innovative cancer treatments through collaborations like ArsenalBio for T cell therapies.

The company emphasizes digital health technologies, enhancing clinical trial management and patient engagement.

BMS offers both innovative and generic medicines, increasing affordable healthcare solutions.

Upsides

BMS's partnership with Medidata enhances clinical research processes and patient outcomes.

The collaboration with AI Proteins advances novel miniprotein-based therapeutics, expanding therapeutic modalities.

BMS's global license agreement with BioArctic expands its portfolio in neurodegenerative diseases.

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