Associate Director, Data Management

Wave Life Sciences is a biotechnology company focused on unlocking the broad potential of RNA medicines to transform human health. Our RNA medicines platform, PRISM, combines multiple modalities, chemistry innovation and deep insights in human genetics to deliver scientific breakthroughs that treat both rare and prevalent disorders. Our toolkit of RNA-targeting modalities includes editing, splicing, RNA interference and antisense silencing, providing us with unmatched capabilities for designing and sustainably delivering candidates that optimally address disease biology. Our diversified pipeline includes clinical programs in Duchenne muscular dystrophy, Alpha-1 antitrypsin deficiency and Huntington’s disease, as well as a preclinical program in obesity. Driven by the calling to “Reimagine Possible”, we are leading the charge toward a world in which human potential is no longer hindered by the burden of disease.

Description:

Associate Director, Data Management at Wave Life Sciences will be responsible for the day-to-day data management activities on the studies in the assigned program. The successful candidate will oversee execution of CRO outsourced trials from study startup through study closure in support of trial objectives and corporate goals. Key duties include study database set up, review and oversite of data cleaning, and close out responsibilities. This role works closely with the CRO data managers to ensure on-time delivery of quality data management deliverables. Flexible hybrid work schedule located in Lexington, MA. This position reports to the Head of Data Management.

Experience:

• Requires a bachelor’s degree in a scientific discipline or equivalent
• At least 12 years of clinical data management experience in pharma/biotech/CRO industry
• At least 7 years of Electronic Data Capture (EDC) experience with systems such as Medidata Rave
• Global clinical trial and CRO management experience

Responsibilities:     

• Provide oversight of clinical data management activities across multiple studies within the assigned program
• Oversight of Data Management external vendors (CROs) for outsourced study activities such as CRF development, database set-up activities, data validation process, medical coding, SAE reconciliation, training of study site personnel in CRF completion, lab data transfer specifications, and data clarification processes
• Oversee and perform thorough testing of the eCRFs prior to database deployment and ensure proper documentation of testing per the SOPs
• Oversight of data review activities, ensure completion of all activities for deliverables and manage all activities leading to the study database lock
• Recognize potential CRO performance issues and escalate them effectively for resolution
• Where applicable, ensure consistency and data standards are followed across studies in data collection and processes
• Provide creative and effective ways to resolve complex data related or system related issues using professional concepts and considering company objectives
• Ensure Data Management activities are conducted according to applicable regulations and per the protocol
• Oversee or prepare Case Report Form (CRF) specifications and CRF Completion Guidelines
• Oversee or develop Data Management Plan
• Serve as the study Data Manager on assigned clinical trials and attend clinical trial study team meetings
• Serve as the technical consultant ensuring appropriate development, maintenance, and use of data capture technologies for assigned projects
• Contribute as a reviewer from Data Management group for study protocols and amendments to the protocols
• Responsible for archival of data and study specific data management documentation
• Independently monitor own activities and project status for successful project deliverables according to timelines
• Participate in the review and/or development of SOPs and guidance documents

Key Skills:

• Knowledge of CDISC (CDASH, SDTM) and medical coding dictionaries MedDRA, WHO Drug, and Clinical Data Management best practices
• Good understanding of ICH, GCP and other applicable regulatory guidelines
• Effective verbal and written communication skills
• Demonstrated ability to work independently on multiple studies with multiple priorities in a fast-paced, team-based environment
• Demonstrated ability to work cohesively within Data Management function and within the study team

Wave Life Sciences provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, Wave Life Sciences complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

Wave Life Sciences expressly prohibits any form of workplace harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status. Improper interference with the ability of Wave Life Sciences’ employees to perform their job duties may result in discipline up to and including discharge.

We value our relationships with professional recruitment firms. To protect the interests of all parties, and given the large volume of inquiries received from third-party placement agencies, we are not able to respond to all agency inquiries. We do not accept unsolicited resumes from any source other than directly from candidates for current or future positions. Submission of unsolicited resumes in advance of a signed agreement between our company and a placement agency does not create an implied obligation and, if an unsolicited candidate represented by a placement agency is hired, we are not obligated to pay a fee. Only approved recruitment firms will be allowed to provide services to Wave Life Sciences, USA.