Sr. Associate Manager Clinical Data Management

Overview: * Manage the creation, execution and maintenance of Data Management Plans in support of clinical study deliverables. * Lead the design, creation and lifecycle management of data collection, validation and reporting specifications and usage guidelines. * Support the training and development of certain CDM study personnel (e.g. Clinical Data Analyst I & II's) through formal training and guided mentorship. * Support the preparation of project budgets and financial reporting. * Assist in the development of study resourcing plans and direct the activities of certain CDM study personnel. * Accountable for the delivery of fit-for-use and regulatory-compliant clinical study data. * Represent CDM in study team meetings and facilitate cross-functional activities * Partner and openly communicate with the study team to proactively address operational issues and clinical data questions. * Manage partnerships with External Service Providers (ESPs) (e.g. CROs, EDC Vendors, Central Labs) in order to support business goals and further the mission of CDM. Qualifications * Excellent analytical, problem-solving, organizational, time-management, interpersonal and communication skills * In depth knowledge of all aspects of the clinical trials process from pre-clinical to post-marketing phases * Ability to interpret and apply regulatory requirements * Knowledgeable concerning all aspects of qualification and compliance assessments * Demonstrated ability to effectively develop and manage relationships with ESPs * Technical understanding of clinical research technologies and data validation methodologies * Knowledge of systems integration and data interchange standards * Proficient in the use of one or more of the leading Clinical Database Management Systems * Experience supporting continuous process improvement initiatives with a proven track record of success as measured by return on investment * Current with industry developments, trends and opportunities Education and/or Experience: Minimum: BA/BS + 4 years experience or equivalent. Preferred: Master's degree in a related field. 3+ years of CDM experience in the Pharmaceutical, Device or Biotech industries (Sponsor, CRO or combination) in roles of increasing responsibility.

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