Seeking a Senior Manager, Clinical Data Management to join the Clinical Data Management group within the Biometrics function. We are seeking a highly-motivated, quality-focused individual to work collaboratively in a fast-paced, cross-functional team environment. The Sr. Manager, CDM will oversee clinical data management activities across multiple studies from study start-up through study closure in support of clinical trial objectives and corporate goals. This individual will play a key role in ensuring complete, accurate, high quality clinical data for outsourced trials. This position will report to the Head of Data Management.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Oversee clinical data management (CDM) activities across multiple studies.
Represent CDM in cross-functional meetings.
Ensure DM project deliverables are completed on time and in accordance with quality standards and requirements from study start-up through study closure/archival.
Establish and maintain strategic business relationships with CDM vendors; apply effective vendor management throughout the study.
Responsible for ensuring complete and accurate CDM documentation such as eCRF specifications, eCRF completion guidelines, annotated CRFs, data validation specifications, data transfer agreements and data management plans.
Perform thorough development testing of the eCRF prior to deployment, inclusive of creating User Acceptance Test (UAT) Plans, Test Scripts and execute testing as applicable.
Ensure accurate development and execution of data integrations between EDC, IXRS and/or external vendor data sources.
Responsible for setup and management of data transfers for assigned studies, including review of test data transfers for consistency with data transfer agreements.
Participate in the RFP process including the evaluation of potential vendors.
Participate in study document reviews, e.g. clinical study protocols, statistical analysis plans, Mock Tables, Figures and Listings (TFL) shells.
Perform supplemental data reviews according to the data quality checks outlined in the data validation specifications or Clinical Data Review Plan (CDRP).
Participate in reviews of blinded TFL output prior to final database locks.
Report query trends and data/query/SDV metrics to the Study Management Team (SMT).
Participate in the development of EDC custom report specifications or SAS Clinical Programming report specifications as needed.
Prioritize projects and coordinate data management activities in support of corporate goals and objectives.
Participate in the development and/or enhancement of CDM department standards, operational procedures and best practices.
Assist with strategic planning activities for the CDM department and participate in the implementation of new departmental initiatives.
Address the business needs of CDM functional customers.
Demonstrate a commitment to company values: Patient First, Passion for Science, Success Together, Imagine and Innovate, and Lifelong Learning.
5+ years clinical data management experience in the pharmaceutical/biotech or CRO setting.
5+ years of hands-on Electronic Data Capture (EDC) experience
Experience running Ph1-Ph3 clinical trials, both directly (in-house) and outsourced to CRO vendors.
Experience with writing SOPs, Work Instructions, Data Management Plans and Guidelines.
Experience with SAS or SQL programming techniques with clinical data management application a plus.
Knowledgeable in GCP standards, CDISC standards (CDASH, SDTM, ADaM), FDA and ICH guidelines, and recommended CDM Best Practices.
Logical thinking, attention to detail and accuracy, good organizational skills, and problem-solving abilities.
Ability to thrive in a fast-paced environment and adapt to changing business conditions with a "can-do" attitude.
Ability to work effectively in both a team setting and independently.
Strong interpersonal, organizational, and communication (written and verbal) skills.
Ability to multitask, prioritize and coordinate activities strategically in support of corporate goals and objectives.
Desire to be part of a values based, highly innovative cardiovascular company aimed at transforming the lives of patients and their families.
Willing to travel if required.