Associate Director/Director, Data Management

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Job description

Benefits Offered

401K, Dental, Life, Medical, Vision

Employment Type

Full-Time

"We deliver innovative treatments to improve the lives of individuals suffering from neuropsychiatric, neurologic and other disorders"

Intra-Cellular Therapies is a biopharmaceutical company committed to the development of novel CNS drugs, leveraging innovative technology based on the pioneering efforts of ITCI co-founder and Nobel laureate, Dr. Paul Greengard. ITCI has a diverse portfolio of approved and investigational compounds across different stages of clinical development. Our lead candidate, lumateperone (CAPLYTA ), is FDA-approved for the treatment of schizophrenia in adults as well as for the treatment of bipolar depression in adults as monotherapy and as adjunctive therapy.

Associate Director/Director, Data Management will oversee and provide guidance (both technical and strategic) on data management services provided to Intra-Cellular Therapies by CROs and will manage all aspects of data management for clinical studies including data entry, EDC Design and UAT, discrepancy management, database updates, adverse events and concomitant medications coding, data reporting, database audits, database locks, and data transfers.

Responsibilities:

• Provide data management technical guidance to cross-functional study teams including the Clinical team.
• Perform and closely monitor/manage user acceptance testing and technical reviews.
• Provide expertise regarding the interpretation of regulations and policies as they relate to critical compliance areas for clinical trials.
• Provide direction to study team to maximize compliance with regulatory requirements; review and suggest improvements to operating procedures and policies where appropriate.
• Review and provide input in protocol, clinical reports, and other documents reviewed in the study team.
• Contribute and drive ongoing process improvement initiatives.
• Ensure standard procedures for study and data management are in compliance with industry practices and company policies and procedures.
• Ensure data system compliance in accordance with the established guidelines of regulatory authorities.
• Provide assistance in preparation and submission of regulatory documents.
• Provide regulatory guidance to the study team in the planning and development of the studies through submission.
• Provide regulatory support during internal and external audits.
• Provide sponsor oversight of data management activities, ensuring data management timelines and regulatory compliance including maintenance of study documentation and staff competencies.
• Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
• Participate in the preparation and presentation of data, when needed.Serves as an educational and training resource within the company to medical affairs, sales and marketing colleagues
• Executes on administrative tasks in a timely and compliant manner (eg. expense reports, field activity reports, company vehicle documentation, compliance trainings and certifications)
• Understands and contributes toward a positive team culture, promotes a cohesive work environment including participating in company's/team's work or social activities
• Additional duties as assigned by the Company
• Complete all company-based and job-related training as assigned by the Company within the required timeline
• Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice

Requirements:

• Bachelor, Master, or PhD in quantitative or health related fields or closely related field
• For Associate Director: Minimum of 7 years of experience in Data Management in pharmaceutical clinical trials (preferably 3+ years from a pharmaceutical company and the rest from CRO, or research centers)
• For Director: Minimum of 12 years of experience in Data Management in pharmaceutical clinical trials (preferably 5+ years from a pharmaceutical company and the rest from CRO, or research centers)
• Strong interpersonal skills and working knowledge of FDA/EU and ICH-GCP regulations and guidelines
• Capable of collaboratively engaging with external 3rd parties such as CROs or external consultants
• Experienced in all phases of drug development
• Flexible in the face of shifting needs and/or priorities
• Able to interface well with all levels of personnel, including peers and other department heads
• Familiarity with computerized systems and compliance requirements
• Ability to produce high quality results across multiple projects and prioritize demands
• Must be able to perform all essential functions of the position, with or without reasonable accommodation
• Complete all company and job-related training as assigned within the required timelines.
• Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. Must be able to perform all essential functions of the position, with or without reasonable accommodation.

Intra-Cellular Therapies is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, protected veteran status, disability or any other legally protected status.

Associate Director, Data Management: Base Salary Range $130,000 - $165,000

Director, Data Management: Base Salary Range $170,000 - $200,000

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