Senior Manager, Clinical Data Management

Myokardia South San Francisco , CA 94080

Posted 6 months ago

SUMMARY:

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.

EDUCATION/EXPERIENCE/SKILLS:

Education:

  • Minimum of a Bachelor of Science degree in a scientific discipline or equivalent college program.

Experience:

  • 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.

Knowledge/Skills/Abilities:

  • 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.

icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Manager Data Management

Johnson & Johnson

Posted 1 week ago

VIEW JOBS 10/11/2019 12:00:00 AM 2020-01-09T00:00 Janssen is looking to hire Manager of Data Management at its South San Francisco office. Actelion Pharmaceuticals Ltd., a Janssen Pharmaceutical Company of Johnson & Johnson, is recruiting for Manager of Data Management to be located in South San Francisco, CA. As part of the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We collaborate with the world for the health of everyone in it. Actelion is a leader in the field of pulmonary arterial hypertension (PAH). Our portfolio of PAH treatments covers the spectrum of disease, from WHO Functional Class (FC) II through to FC IV, with oral, inhaled and intravenous medications. Working as part of Janssen's Data Strategy and Management team, the Manager, Data Management, Pulmonary Arterial Hypertension, will oversee data operations for Janssen's Pulmonary Arterial Hypertension (PAH) therapeutic area. The Manager will ensure the ongoing successful integration and quality of data critical to sales and marketing functions – including Specialty Pharmacy Data -- and will ensure data readiness to support sales operations (targeting, field reporting, incentive compensation), insights and analytics, forecasting, and other commercial functions. The Manager will maintain strong cross-functional partnerships across supported team while working as a member of Janssen's larger Data Strategy and Management Organization. Key Responsibilities: The Manager, Data Management, Pulmonary Arterial Hypertension, is responsible for the following: * Stewarding the Pulmonary Arterial Hypertension (PAH) therapeutic area's data, which is sourced primarily from Actelion's Hub and Specialty Pharmacy Provider (SPP) network. * The Manager actively monitors and manages the day-to-day quality of SPP data, leading day-to-day oversight of SPP data management processes and partners, ensuring data readiness across the full range of uses and dependent functions. * The manager oversees key data quality assurance processes and data quality reporting, and also reporting related to REMS programs. * The Manager partners with Data Stewards to manage related data assets into Janssen's commercial data processing environment (CDP), including shipment tracking, exception reporting, product performance metrics, managed care information, and customer profile information used across the range of sales and marketing operations and analytics. * The manager leads continuous improvement projects involving data management activities, including managing project timelines, budget, and outcomes, and will facilitate additional related projects within the Data Strategy and Management team. * Based in San Francisco, the Manager will be required to work independently and to lead cross-functional teams and projects, and to work effectively as part of a multi-location team including San Francisco, Horsham (PA), and Titusville (NJ). Qualifications * A Bachelor's degree is required. * Minimum of 5 years of industry experience is required. * Healthcare experience preferred. * General business analysis experience is required. * Advanced data access skills such as SQL is required. * Advanced data access skills such as SAS or other advanced tools preferred. * Advanced knowledge of Excel, Access, PowerPoint, and the ability to organize data/information are required. * Experience with Specialty Pharmacy Data is required. * Knowledge of REMS program and audit compliance are highly desired. * Data management operations and integration (profiling, match/merge, migration, testing, standards, documentation) are required. * Tableau experience highly preferred. * Strong written and verbal communication skills are required. * Analysis experience with pharmaceutical sales or the healthcare industry required. * Knowledge of Affiliations and management is preferred. * Experience with integrating data from disparate sources is required. * Travel: Up to 15% domestic travel Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Primary Location United States-California-South San Francisco- Organization Actelion Pharmaceuticals US Inc (6252) Job Function Marketing Requisition ID 0285190724 Johnson & Johnson South San Francisco CA

Senior Manager, Clinical Data Management

Myokardia