Project Data Manager

The Project Data Manager (PDM) leads and oversees 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.??

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

This position oversees day-to-day operations and coordinates planning and operational activities of assigned junior team members, like, CDM1, CDM2 and CDM3 and their assigned projects.

The PDM is a member of the Data Management staff.

Requirements

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)

As a Project Manager for Biometrics stand-alone studies, the Project Data Manager will:

Lead and coordinate the Biometrics project team, ensuring the project is delivered according to planned scope and timelines in accordance with the contract

Create and execute project management plans required for project delivery and in accordance with established processes

Establish requirements for and ensure project-specific training plan for internal team members

Establish clear communication lines and escalation pathways, communicate with project stakeholders, both internally (e.g. Clinical Programmers, Data Scientists, Biostatistics and other functional groups) and externally (e.g. sponsors, vendors (EDC, external data) and other external parties)

Establish requirements for and ensures project-specific training plan for internal team members

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)

As a Project Manager for Biometrics stand-alone studies, the Project Data Manager will:

Lead and coordinate the Biometrics project team, ensuring the project is delivered according to planned scope and timelines in accordance with the contract

Create and execute project management plans required for project delivery and in accordance with established processes

Establish requirements for and ensure project-specific training plan for internal team members

Establish clear communication lines and escalation pathways, communicate with project stakeholders, both internally (e.g. Clinical Programmers, Data Scientists, Biostatistics and other functional groups) and externally (e.g. sponsors, vendors (EDC, external data) and other external parties)

Establish requirements for and ensures project-specific training plan for internal team members

Establish project risk management plan with input from client and functional stakeholders and oversee adherence and updates throughout the project lifecycle

Lead internal meetings with internal team members and external meetings with a sponsor, 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

In addition, as a Project Manager for Biometrics stand-alone studies and/or large, complex or multiple studies with same client, the Project Data Manager will:

Lead the Biometrics project team, ensuring the project is delivered according to planned scope and timelines in accordance with the contract

Ensure overall consistency across all client studies within a set of projects; this especially relates to the DM activities; Data Management Plan (DMP), CRF design, data cleaning and query management) and for Biometrics stand-alone projects also include statistical deliverables (SAP, TLFs)

Lead internal meetings with internal project team members. Support and participate in external meetings with a sponsor, including Kick Off Meetings (KOM) and Investigator Meetings based on project scope

Interact, negotiate and influence internal and external team members in a professional manner and with successful outcomes

Ensure effective and efficient resource utilization across projects and programs

Manage the study budget, evaluate financial project health and manage monthly status updates for invoicing. Participate in monthly project review meetings

Proactively recognize and address any changes in scope. Liaise to execute contract amendments

Oversee Sponsor relationships

Assist in contracts negotiation and contracting process with vendors (EDC, IRT)

May support operational Data Management activities, also to ensure and assess quality

Oversee and ensure the Trial Master File for DM services in scope is kept up to date and audit/inspection ready.

Contribute to other areas of business as required

Research, propose and lead initiatives for improving efficiency

Manage direct reporting staff, perform performance reviews and support team member personal development plans

Oversee and supervise work done by junior team members (CDM1 level - CDM3 level)

Actively support to staff learning & development within the company

Share relevant information at applicable DM departmental meetings and organize and lead DM-related meetings and discussions

Represent the company through active participation at professional meetings, webinars or seminars

Provide and coordinate Data Management training for relevant staff. Support in development of new training material

Train and mentor data managementstaff, support in development of new training material and provide training to relevant staff

Participate in the interview process for new recruits

Proactively track Data Management related regulatory development trends and updates, in consultation with department Global Head and/or Senior Directors, for further alignment and improvement of current processes

Quality Management

Contribute as Clinical Data Management Subject Matter Expert (SME) to the evaluation/improvement/drafting of processes and procedures within the Quality Management System

Account Management, Sales & Acquisition

Assure good communication and relationships with (future) clients

Contribute to and take part in client evaluations and visits

Support in preparation of new proposals and budgets for Data Management services

Support Business Development (BD) in preparing and providing presentations to potential and existing clients through attendance at capabilities and/or bid defense meetings

Provide input into tools and templates to support costing and bidding

Others

Contribute to other areas of business as required

10% Travel

Education Requirements and Qualifications

Qualifications

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

Minimum 8 years of relevant experience in related clinical trials environment

Thorough knowledge and understanding of ICH-GCP, 21CFR11 data privacy (GDPR/HIPPA) guidelines and awareness of local/regional requirements

Good understanding of Medical Terminology

Experience as DM Lead on several studies and experience in covering all phases of a clinical study (start up, conduct and database lock). Worked on multiple indications and clinical phases (I-IV)

Thorough understanding of relational database components and experience in technical data management practices (validation plans, testing, and documentation

Experienced in CDISC conventions, i.e., CDASH, TAUG models and hands on experience implementing these models

Client management experience

Experience in developing data management standards

Skills

Strong written and verbal communication skills including good command of English language

Representative, outgoing and client focused

Ability to work in a fast-paced challenging environment of a growing company

Proficiency with various computer applications such as Word, Excel, and PowerPoint required

Administrative excellence

Attention to detail, strong technical, analytical and problem-solving skills

Strong project management skills

Ability to translate guidelines, rules and regulations in clear and usable recommendations

Ability to simplify complex issues into understandable concepts

Excellent organizational, negotiating and motivational skills

Benefits

Benefits of working at Allucent include:

• Comprehensive benefits package per location
• Competitive salaries per location
• Departmental Study/Training Budget for furthering professional development
• Flexible Working hours (within reason)
• 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 via GoodHabitz and internal platforms
• Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects
• Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees

Disclaimers:

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. Candidates should never be submitted directly to our hiring managers, employees, or human resources.