Associate Director, Clinical Data Management

Description ASSOCIATE DIRECTOR, CLINICAL DATA MANAGEMENT Job Summary The Associate Director, Clinical Data Management will lead Data Management for multiple clinical studies and/or a clinical development program. Reporting to the Senior Director, Clinical Operations, the incumbent will provide leadership and guidance for all phases of clinical studies from the EDC study design through to study closeout and be responsible for the oversight and management of clinical data management activities outsourced to CROs. Key Roles And Responsibilities Responsible for the oversight of Clinical Data Management deliverables, including activities outsourced to CROs to ensure adherence to the protocol, the scope of work and service agreements, ensuring high quality and integrity of all deliverables. Ensure CRO adherence to project timelines, from study startup through study closeout. Collaborate with clinical study teams and vendors to ensure project deliverables are met with clinical study data acquisition, quality data review, and reporting in compliance with GCP, SOPs, and regulatory requirements. Develop Data Management metrics and key performance indicators to aid in the oversight and management of CRO partners. Serve as primary point of escalation for CRO for data management Lead internal data review for assigned clinical studies. Identify and mitigate risk to data integrity driving for timely resolution. Assist in identifying data trends and report on performance and quality Develop requirements/specifications for outsourcing data management to vendors. Works with Program Management team for review of vendor proposals, contracts, scope changes / change orders, and budgets for accuracy with respect to data management activities. Perform reconciliation of vendor invoices for accuracy as needed Participate in vendor qualification visits and audits. Lead or contribute to the development, review, and implementation of Clinical Data Management processes, policies, and SOPs. Proficiency in, and ability to learn, new clinical systems including EDC, IWRS/IRT/RTSM, CTMS, eTMF and other clinical project management tools required. Lead data management study inspection readiness activities and support of submission activities as needed. Train and mentor DM staff or internal team members on processes, projects, systems, and programs. Perform hands-on data management responsibilities, if required. Other activities may be assigned as required Required Qualifications BS degree or equivalent required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, and Pharmacy). Minimum of 8 years clinical trial experience in the pharmaceutical, biotech industry, clinical trial site, or CRO Experience managing a CRO, including quality and performance oversight Experience in the set-up and management of third-party vendors. Preferred Qualifications Experience with phase global phase III clinical trials for a biotechnology company, preferably with Vaccines. Experience in Industry Standards for Case Report Form development (i.e., CDISC/CDASH). Familiarity with SDTM and Adam models Experience with Medidata Rave (EDC) is preferred. Knowledge, Skills, And Abilities Thorough knowledge of FDA, CFR and ICH GCP requirements and other regulatory requirements. Ability to communicate technical concepts clearly and concisely to non-technical colleagues. Strong organizational skills, attention to detail, and self-motivated. Team player, with the ability to work successfully across functions. Can thrive in a fast-paced environment with rapid change while effectively managing pressure in a professional manner. Flexibility in work hours as needed to accommodate international collaborators or significant meetings/events. PHYSICAL DEMANDS Performing the responsibilities of the job requires ability to use hands and fingers to handle or feel and to manipulate keys on a keyboard. Occasionally required to stand, walk, reach with arms and hands, climb or balance, and to stoop, kneel, crouch or crawl. Ability to read and type while sitting in front of a computer up to 4 hours at a time. Vision abilities required by this job include close vision. May occasionally have to lift, tug, and pull up to 25 lbs. WORK ENVIRONMENT This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. Curevo offers its employees a generous range of compen