Director, Data Management

Chennai, Tamil Nadu, India

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Allucent, a clinical research organization striving to bring new therapies to light by solving distinct challenges of small and mid-sized biopharma companies.

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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.


The Director, Data Management (DDM) is responsible for the overall performance, quality, planning, and execution of data management services in accordance with the standard operating procedures, regulatory guidelines, executed client contract and the clients’ expectations. This position provides direction, high-level expertise and leadership in improvement of data processes, systems and organization in alignment with other functional heads.



Management

· Analyze and implement new development plans and actively participate in the Director team (strategy – leadership – business integration) meetings to identify and implement department related goals and strategies · Contribute to development of annual revenues, sales, profit and operational targets for the Data Management · Evaluate and contribute to the development of the department strategy and tactics planning · Manage direct reporting staff · Develop and agree upon operating procedures / business processes · Ensure the availability of required capable resources for the department · Working closely with the Global head of Data Management, Directors and functional heads of other departments so that global consistency, focus and development are achieved across the company · Collaborate and ensure open communication with other functional groups and departments · Report to the leaderships team · Ensure activities meet and integrate with organizational requirements for quality management, health and safety, legal stipulations, environmental policies and general duty of care

Data Management ·

Implement standardization of data management to complete project deliverables on schedule and according to quality standards and requirements of the study · Collaborate with Data Management team on study start up tasks and during the project execution to ensure success of overall project. · Plan and project the resources required across the project(s) including management of tasks, timelines, risk and quality · Serve as project advisor to project teams regarding operational aspects of a project. · Develop solutions to increase the efficiency of other teams · Manage executed contract and financial aspects of projects

· Formulate short-term and long-term strategies to improve data management & programming efficiencies · Conduct and/or support hands-on Data Management operational activities

Learning & Development

· Actively manages and mentors Data Management staff in general skills, project management skills, internal company processes and for project specific tasks · Conduct performance evaluation · Participates in the interview process for the new recruit · Represent the company at professional meetings or seminars · Actively contribute to staff learning & development within the company · Provide and coordinate Data Management training for relevant staff · Proactively track data management development trends and updates, in consult with department head, for further alignment and improvement of current processes

Quality Management ·

Review, improve and evaluate Data Management processes and procedures within the Quality Management System

Account Management, Sales & Acquisition

· Monitor and assure client satisfaction on existing projects · Identify key accounts and maintain strong long-lasting relationships to win new and repeat business · Support in preparation of new proposals · Contribute and take part in client evaluations, visits and bid defenses

Others

. Contribute to other areas of business as required

Requirements

Life science, healthcare and/or business degree · Minimum of 15 years of relevant data management experience within Contract Research Organization (CRO), Pharmaceutical or biotech industries · Minimum of 15 years of experience in drug development and/or clinical research · 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 · Demonstrated experience in senior management positions and people management

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 · Administrative excellence · Proficiency with various computer applications such as Word, Excel, and PowerPoint required · Strong leadership skills · Project management skills and experience · 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, negotiating and financial skills

Tags: Data management Excel GCP Research

Perks/benefits: Startup environment

Region: Asia/Pacific
Country: India
Job stats:  3  0  0
Category: Leadership Jobs

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