Senior Manager Data Management

Allucent is a full-service contract research and development organization with international resources dedicated to helping pharmaceutical and biotechnology companies efficiently and expeditiously navigate the regulatory approval process in order to bring new drugs, biologics, and medical devices to the people who need them. Allucent is a non-laboratory environment. At Allucent, our mission is to help bring new therapies to light. When you work at Allucent, that means rolling up your sleeves and applying your scientific knowledge, clinical expertise, and experience to partnerships with our clients in small and mid-sized biotech companies.

The Senior Manager, Data Management manages, directs and oversees all planning and operational activities of Data Management from study start-up to execution, study closure, final reporting and archiving by maintaining high standard of quality and within contractual budget and timelines.

This position provides guidance and expertise in relevant data management areas and cross-functional initiatives, including the development of departmental processes, tools, and training of staff.

Key Responsibilities:

• Line manage, direct, lead, develop and supervise data managers.
• Responsible for managing, leading and mentoring staff.
• Responsible for all data deliveries for assigned projects within time and budget with highest priority applied to data quality.
• Responsible for the planning, organization, and coordination of Data Management activities in a set of projects belonging to one or more clients; such that quality, timelines and budget meet expectations.
• Manage contractual and financial aspects of projects
• Responsible for developing, maintaining and manage and meeting client expectations.

• Identify quality issues. Implement and monitor any remediation actions that may be necessary.
• Collect timely feedbacks and conduct performance evaluation.
• Participates in the interview process for the new recruit.
• Support Business Development (BD) in preparing and providing presentations to potential and existing clients through attendance at capabilities and/or bid defense meetings via telephone conference or personal attendance.
• May represent the company at professional meetings or seminars
• Demonstrates Allucent core competencies at the management level; exhibits Allucent values.

• Provide, initiate or coordinate training necessary for the staff to be efficient and productive with a strong focus on quality.
• May support training initiative in conjunction with BBU representative.

Requirements

Qualification:

• Life science, healthcare and/or relevant degree
• Minimum of 8+ years of relevant core clinical data management experience within Contract Research Organization (CRO), Pharmaceutical or biotech industries
• Proven strong people management experience of 5+ years
• Project management experience
• Thorough knowledge of ICH-GCP(R2), GDPR/HIPPA, CDISC, GCDMP and applicable (local) regulatory requirements
• In-depth knowledge of clinical trial processes, EDC systems, database programming, clinical operations, quality management, and systems applications to support operations
• Proficiency in the data management practices, including tools and processes
• Ability to translate guidelines, rules and regulations in clear and usable recommendations

Specific Skills:

• Strong written and verbal communication skills including excellent command of English language
• Representative, outgoing and client focused
• Ability to work in a fast-paced challenging environment of a growing company
• Administrative excellence
• Proficiency with various computer applications such as Word, Excel, and PowerPoint required
• Project management skills and experience
• Proactive and excellent time management skills
• Eye for detail, strong analytical and problem-solving skills
• Effective at problem solving, strategic thinking and conflict resolution
• Strong presentation and networking capabilities
• Excellent organizational,interpersonal, negotiating and financial skills
• Flexible, Ability to collaborate and work in a global setup