Project Data Manager (Europe)

Allucent; Bracknell; Hybrid; GBP 40,000 - 80,000; Full time

Job summary

Join a forward-thinking company as a Project Data Manager, where you'll lead data management activities for clinical trials. This role is vital in ensuring the accuracy and consistency of clinical data, managing timelines and budgets, and coordinating with internal and external stakeholders. You'll have the opportunity to work in a hybrid environment, participate in professional development, and contribute significantly to the success of life-changing therapies. If you're passionate about making an impact in the biopharmaceutical industry, this is the perfect opportunity for you.

Benefits

Comprehensive benefits package

Competitive salaries

Flexible working hours

Leadership and mentoring opportunities

Internal growth opportunities

Access to online training

Departmental Study/Training Budget

Qualifications

• Minimum 8 years of experience in Clinical Data Management or related fields.
• Thorough knowledge of ICH-GCP and data privacy guidelines.

Responsibilities

• Lead data management activities and ensure data quality standards.
• Manage project timelines, budgets, and vendor relationships.

Skills

Clinical Data Management

Project Management

Communication Skills

Analytical Skills

Problem-Solving Skills

Education

Life Science Degree

Healthcare Degree

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Job description

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At Allucent, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.

We are looking for a Project Data Manager (PDM) to join our A-team (hybrid*/remote). As a PDM at Allucent, you are responsible for leading and overseeing data management activities, timelines, and finances of the Allucent Data Management (DM) department. This position manages and coordinates DM deliverables from database design & set-up, through cleaning and reporting to database locking, ensuring that the completeness, accuracy, and consistency of clinical data meets the quality standards and regulatory requirements for analysis and reporting.

Additionally, this position acts as a Project Manager and is responsible for the overall coordination and management of Biometrics standalone projects, large and complex trials, and/or multiple projects belonging to one client.

The PDM is a member of the Data Management staff.

In this role, your key tasks will include:

• Lead and serve as primary contact for DM with all relevant parties both internally (e.g., Biostatistics and if applicable other functional groups, such as Project Management, Clinical Operations) and externally (e.g., sponsors, vendors (EDC, external data), investigational sites).
• Lead and coordinate the Biometrics project team, ensuring the project is delivered according to planned scope and timelines.
• Create and execute project management plans required for project delivery and in accordance with established processes.
• Establish requirements for and ensure project-specific training plans for internal team members.
• Establish clear communication lines and escalation pathways, communicating with project stakeholders, both internally and externally.
• Establish project risk management plans with input from clients and functional stakeholders and oversee adherence and updates throughout the project lifecycle.
• Lead internal meetings with internal team members and external meetings with sponsors and third-party (data) vendors, including Kick Off Meetings (KOM) and Investigator Meetings based on project scope.
• Provide support for vendor identification, qualification, and selection and manage vendors.
• Manage vendors and vendor relationships as required for project delivery.
• Arrange, maintain, and circulate project progress and status reports.
• Ensure overall consistency across all client studies within a set of projects, especially relating to DM activities.
• Interact, negotiate, and influence internal and external team members in a professional manner with successful outcomes.
• Manage the study budget, evaluate financial project health, and manage monthly status updates for invoicing.
• Proactively recognize and address any changes in scope.
• Oversee and ensure the Trial Master File for DM services in scope is kept up to date and audit/inspection ready.
• Actively support staff learning & development within the company.
• Represent the company through active participation at professional meetings, webinars, or seminars.
• Contribute as Clinical Data Management Subject Matter Expert (SME) to the evaluation/improvement/drafting of processes and procedures within the Quality Management System.

Requirements:

• Life science, healthcare degree and/or combination of education and experience.
• Minimum 8 years of relevant work experience in Clinical Data Management or related experience within Biometrics.
• Thorough knowledge and understanding of ICH-GCP, 21CFR11 data privacy (GDPR/HIPPA) guidelines.
• Good understanding of Medical Terminology.
• Experience as DM Lead on several studies covering all phases of a clinical study.
• Thorough understanding of relational database components and experience in technical data management practices.
• Experienced in CDISC conventions, i.e., CDASH, TAUG models.
• Client management experience.
• Strong written and verbal communication skills including good command of English language.
• Ability to work in a fast-paced challenging environment of a growing company.
• Proficiency with various computer applications such as Word, Excel, and PowerPoint.
• Attention to detail, strong technical, analytical, and problem-solving skills.
• Strong project management skills.

Benefits:

• Comprehensive benefits package per location.
• Competitive salaries per location.
• Departmental Study/Training Budget for furthering professional development.
• Flexible Working hours (within reason).
• Opportunity for remote/hybrid working depending on location.
• Leadership and mentoring opportunities.
• Participation in our enriching Buddy Program as a new or existing employee.
• Internal growth opportunities and career progression.
• Financially rewarding internal employee referral program.
• Access to online soft-skills and technical training.

Disclaimers:

*Our hybrid work policy encourages a dynamic work environment, prescribing 2 days in office per week for employees within reasonable distance from one of our global offices.

The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively 'Allucent'). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency.

Seniority level

Mid-Senior level

Employment type

Full-time

Job function

Information Technology

Industries

Technology, Information and Internet