Principal Project Data Manager (India)

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 Principal Project Data Manager to join our A-team (hybrid*). As Principal Project Data Manager at Allucent, you will be responsible for leading, coordinating and overseeing data management activities, timelines and project 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 takes responsibility for the overall coordination and management of Biometrics standalone projects, large and complex trials, global programs and/or multiple projects belonging to one client.

This position also provides leadership and is a Subject Matter Expert (SME) in relevant data management areas and leads cross-functional initiatives, including the development of departmental processes, tools, and training of 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).
• Provide expert input in improving processes and deliverables that will support improved client relationships.
• Actively monitor for Data Management developments and clinical research-related regulations and share this with DM Directors and team members.
• Lead and coordinate the Biometrics project team, ensuring the project is delivered according to planned scope and timelines in accordance with the contract, with minimal supervision from the Line Manager.
• Create and execute project management plans required for project delivery and in accordance with established processes
• Establish requirements for and ensures 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)
• Establishes 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 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
• Lead the Biometrics project team, ensuring the project is delivered according to the 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 the 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
• Assist in contract negotiation and contracting process with vendors (EDC, IRT, eCOA)
• 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.
• 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 leadership, training, guidance and coordinate Data Management training for relevant staff. Support in the development of new training material.
• Proactively track Data Management regulatory development trends and updates, in consultation with the department Global Head and/or Senior Directors, for further alignment and improvement of current processes .
• Contribute in the field of Clinical Data Management activities to the evaluation/improvement/drafting of processes and procedures within the Quality Management System.
• 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.

To be successful you should possess:

• Life science, healthcare degree and/or combination of education and experience.
• Minimum 12 years or relevant work experience in Clinical Data Management or related experience within Biometrics.
• Minimum 4 years of experience at Project Data Manager level (or equivalent).
• 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.
• Excellent written and verbal communication skills including good command of the 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.
• Attention to detail, strong technical, analytical and problem-solving skills.
• Excellent 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, motivational and influential skills.

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)
• 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 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:

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