Director Data Mgmt (DG)

Northern, NJ - Pharmaceutical & Biotech - Hybrid

Date Posted: 1/3/2023 11:13:28 AM

Director Data Management
255K base+25% bonus, stock around 50K value
Northern, NJ
Hybrid (3 days onsite)

The Director Data Management serves as Data Management Therapeutic Area Head to ensure DM staff, CROs, and vendors are performing in compliance with procedures.

Responsibilities:
Participation on internal study teams to facilitate Data Management communications and coordination. Partner with Head of Data Management to set department and TA objectives, ensuring appropriate staffing levels and resources match demand. Resolves in conjunction with Head of Data Management the department goals, appropriate organizational structure and resource prioritization for data management to meet company’s needs. Advises data management activities according to quality standards, regulatory requirements and ensures adherence to project budget from study start up through archival in support of key development programs. Helps to develop the strategy and vision for building new DM capabilities and clinical data standards, business process and provides use-case direction when adoption of technologies for Data Management and trial management are department goals. Assist in the development of outsourcing strategies and long-term relationships with outsourcing partners.

This role may be for you if:
Working in collaboration with QA and other groups to develop and update data management standard processes and procedures in accordance with CFR, GCP, ICH Guidelines and GCDMP. We need you to be involved in the evaluation of Data Management partners to ensure efficiency and regulatory compliance. Performs all duties expected of a people manager, including but not limited to, recruitment, hiring, performance evaluation, training and the like. Establishes goals and accountabilities for staff and sets annual individual and department goals and objectives.

Requirements:
A Bachelor’s degree in Mathematics, Science or a related field, plus 10 or more years of clinical data management experience in biotechnology, pharmaceutical or health related industry required. 9 + years’ experience of which at least 7 years in direct managing data management group is required.

Please contact Darren Gutowski at dgutowski@clarkdavis.com

255K + Bonus + Stock

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