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Manager, Clinical Data Management

Posted Oct 11, 2019

Job Title: Manager, Clinical Data Management

Location(s): Boston, MA

Posted Oct 11, 2019

Job Title: Manager, Clinical Data Management

Location(s): Boston, MA

Company Overview

Cerevel Therapeutics is a new biopharmaceutical company formed by Bain Capital and Pfizer that relentlessly finds paths through complexity to bring real progress and new treatment options to people living with neurological and neuropsychiatric disorders.

Our portfolio of pre-commercial neuroscience assets targets a broad range of central nervous system (CNS) disorders including Parkinson’s, Alzheimer’s, epilepsy, schizophrenia and addiction.

Headquartered in the Greater Boston area, we are bold thinkers, deep experts, resilient pathfinders, and transparent partners who push the boundaries of scientific understanding to unlock breakthrough CNS therapies that have real impact on people’s lives.

Cerevel aspires to develop and nurture a culture characterized by respect, trust, curiosity, compassion with a relentless focus on mission and results. Our patient- centricity guides our purpose, how we treat each other and what we work on every day. The successful candidate will bring his/her own unique thinking and approach to Cerevel while sharing our core values and convictions.

Role Summary

The Data Science and Innovation Department is seeking a Manager, Clinical Data Management to oversee the day-to-day management of clinical data for global clinical studies. The Clinical Data Manager works with the Clinical Project Team on studies and is the point of contact for all data management (DM) responsibilities. This person is responsible for study database design, data transfers from all third-party vendors and execution of the Data Management Plan, ensuring that all captured data follow the requirements outlined by the protocol and study plans. In addition to being responsible for the successful management of data from individual trials, the CDM will contribute to strategic efforts to harmonize data across trials to enable its seamless re-use for planning future trials.

Key Responsibilities

Serves as primary DM contact in assigned studies for data management tasks from database development, data review and cleaning to database lock and study archive
Oversees the vendors responsible for all Data Management activities and supply study data, inclusive of a Functional Service Provider and CRO
Supervises the development of data management plans, data entry guidelines, data validation specifications, metrics/dashboard reports and other documents as required.
Ensures the data management activities are executed according to the Data Management Plan
Supports database development activities and oversees CRF/database amendment and change control process
Reviews CRFs, data listings, study dashboard and data transfers to ensure all captured data follow the requirements outlined by the protocol and studies plans
Oversees the generation of queries and the resolution of all data related issues prior to database lock
Oversees reconciliations of all third-party data with EDC database and reconciliation of clinical and safety database
Oversees the archive of data management related study documents.
Maintains the Data Management section of the eTMF of assigned studies
Supports the Clinical Project Team and department management in review of study budget, reporting study metrics and ensuring budget compliance
Assists in developing standards for CRFs and external vendor data, including data validation and reconciliation specifications

Required Qualifications

Minimum of two (4) years data management experience, including experience as a Lead Data Manager.
Experience managing CRO and external service providers is preferred
Understanding of CDISC data standards (CDASH and SDTM) and electronic data submission requirements
Experience with at least one database management system. Medidata RAVE experience is preferred
Prior experience using eSource, ePRO, eConsent and IRT systems strongly preferred
Knowledge of ICH and local regulatory authority drug research and development regulations is preferred
Excellent communication and presentation skills
Accountable team player who is organized, efficient, and produces high-quality deliverables
Working knowledge of CDISC and medical terminologies

Desired Qualifications

Attentive to details and able to independently overcome obstacles
Desire to work in a fast-pace, dynamic, technology-driven, innovative environment
Working knowledge of Good Clinical Practices as well as relevant guidance and regulations from regulatory agencies
Knowledge of latest development in clinical research, such as risk-based clinical monitoring

Education

Minimum of a bachelor’s degree, preferably in a life science.
Relevant professional certifications, e.g., Certified Clinical Data Manager, a plus

Cerevel is an Equal Opportunity Employer and does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other characteristic protected by applicable law.

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