Senior Manager/Assoc Director - Clinical Data Management
Cranbury NJ, US
We currently have a permanent opportunity available for, Senior Manager/Associate Director Clinical Data Management with our client in our Cranbury NJ office.
The Senior Manager/Associate Director Clinical Data Management will be responsible for developing and implementing departmental strategies and ensure high customer satisfaction. The Senior Manager/Associate Director Clinical Data Management will be responsible for providing timely and professional ongoing management of Data Management deliverables and of clinical trial data with respect to cost, quality and timelines for assigned trials managed within Clinical Data Management. The position will report to the Head of Data Management.
Role and Responsibilities:
Design and Implementation of CRFs in the database and assuring that the database for each study is live in a timely manner. Oversight of all clinical data management activities, database cleaning and lock activities including developing CRF completion guidelines, edit check specifications, data management plans and data review plans, supervising database development and reviewing and processing clinical trial data to ensure completeness, accuracy and consistency of clinical trials databases across multiple programs (Oncology experience preferred). Good understanding of clinical data flow. Proven Clinical Data Management experience (eg as a Lead Data Manager). Work with the CRO and coordinate activities for the medical review of coding data and approval of adverse events, medical history, concomitant and protocol-related medications. Educate study team members by preparing and distributing study related reports, resolving questions and providing clinical data management guidance. Lead interactions between company, IIT and IST sites and outside vendors on the collection, transmittal and transfer of study specific laboratory data. Participate in cross functional team meetings and communicate with all departments regarding project statuses/issues, provide ongoing feedback on data management workflows to increase efficiency and provide feedback to Clinical Operations. Work closely with safety, clinical operations group, biostatisticians, SAS programmers and other staff as appropriate to develop CRFs to ensure the required information is captured for statistical analysis. Work with biostatisticians and SAS programmers to harmonize data collection, compile and maintain SAS data standards. Provide review and oversight on quality database design, validation, and deployment to ensure quality and efficiencies through data and process standardization. Review clinical study protocols and statistical analysis plans and ensure data quality for data analyses. Take a leadership role in the review and query of clinical data. This includes participation of the critical review of data-populated tables, figures, and listings as part of the database clean-up and prior to database lock. Assure regulatory compliance of vendors and investigational sites with company SOPs, FDA and ICH guidelines, and other applicable regulations and guidelines. Develop and maintain appropriate data management SOPs (associated with the data collection, handling and review processes to meet regulatory compliance and operational needs). Assist in addressing Regulatory Submission issues within Biometrics and with other related departments. Utilize appropriate CDM concepts and resources to solve moderately complex technical CDM issues. Lead initiatives to gather, organize, and analyze interim clinical data from various data sources, and examines issues from various perspectives.
Education: BA/BS, MS or equivalent in a scientific discipline is preferred 5-7 years of progressively more challenging work experience in Clinical Data Management or Project Management. In-depth knowledge of regulatory regulations and ICH guidelines in drug development and approval with good experience in multiple FDA and EMA filings Good organizational and problem-solving skills, as well as the ability to evaluate resource needs Thorough knowledge of Clinical Data Management procedures with good ability to develop and implement a high-quality data system and associated procedures and perform systematic data quality control management. Proficient at creating and communicating a clear vision among team members effectively aligning resources and activities to achieve functional area and/or organizational goals The successful candidate should be a results-oriented, team player with strong interpersonal and communications skills, capable of working collaboratively with colleagues