Senior Clinical Data Manager - Carlsbad, CA | Biospace
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Senior Clinical Data Manager

Ionis Pharmaceuticals, Inc.

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Location:
Carlsbad, CA
Posted Date:
8/25/2017
Position Type:
Full time
Job Code:
17-0057
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Clinical Data Management,

Job Description


Ionis Pharmaceuticals, Inc., located in the North San Diego County city of Carlsbad, was founded in 1989 to create advanced, novel medicines to treat diseases with an unmet medical need. We are the pioneer and leader in the discovery and development of antisense drugs. By exploiting various cutting-edge RNA targeting technologies, we are capable of specifically and efficiently targeting any gene of interest, including ones which are not targetable by small molecules or antibodies. We currently have three approved drugs, and a robust pipeline of over 30 drugs in various stages of clinical trials.

Ionis is a challenging, motivating and rewarding environment designed to foster innovation and scientific excellence. Our success is a direct result of our outstanding employees. We are interested in bringing together individuals with different skill sets into this creative environment to be part of a productive team. Join us and experience our unique culture while you develop and expand your career.

Senior Clinical Data Manager

The Senior Clinical Data Manager (CDM) is accountable for leading the clinical data management (CDM) operational activities for multiple projects, including in rare disease indications. The Sr. CDM is responsible for the planning, implementation, execution and management of multiple clinical trials in various phases of development, per Good Clinical Practice and regulatory requirements and in accordance with development strategy, budget and timeline.

RESPONSIBILITIES

•   Performs/oversees database development and management (e.g., CRF Specifications, Check Specifications, User Acceptance Testing, clean and lock databases)
•   Authors, reviews and/or approves various study related documents and plans (e.g., Data Management Plans, Data Transfer Agreements, CRF Completion Guidelines, Manual Review Guidelines)
•   Manages and performs ongoing CDM activities including CRF review, query generation, receipt and reconciliation of external data, SAE reconciliation, data listing generation and production of CDM summary reports
•   Performs medical coding of data using MedDRA & WHODrug dictionaries
•   Evaluates issues, interprets data, suggests and implements solutions, and mitigates as required
•   Participates in the development of CDM study budgets and manages the budget to expectations
•   Leads vendor selection process for outsourced CDM activities
•   Participates in vendor contract negotiation and execution
•   Oversees External Service Provider (ESPs) engaged to perform data management and EDC activities
•   Assists with oversight of external data providers (e.g., IRT, central and specialty labs, patient diaries)
•   Provides input as the subject matter expert for the study during regulatory inspections
•   Presents at investigator’s meetings and leads data management training
•   Escalates study related issues and communicates as appropriate with management and other functions
•   Represents CDM in study team meetings and facilitate cross-functional activities (e.g. Clinical Data Listing Reviews, database lock activities)
•   Partners and communicates with the study team to proactively address operational issues and clinical data questions
•   Provides periodic status reports regarding study timelines, budget issues, accruals, vendor oversight status, etc. to the Head of Clinical Data Management
•   Liaises and coordinates with document specialists regarding study files
•   Maintains knowledge of therapeutic area, current medical practice and pharmaceutical regulations to ensure best practice across all activities
•   Supports department initiatives and process improvements
•   May mentor/directly supervise other Clinical Data Managers
•   Travel is variable and estimated at a 10% domestic and international

Requirements


COMPETENCIES FOR SUCCESS

•   Excellent analytical and problem-solving skills
•   Outstanding organizational and time-management skills with ability to multitask and prioritize
•   Strong interpersonal and communication skills
•   Demonstrated ability to effectively develop and manage relationships with internal and external stake holders
•   Highly developed leadership skills to successfully lead the Clinical Trial Team through data management activities
•   Ability to think globally and strategically
•   Exceptional attention to detail
•   Flexible to changing priorities
•   Strong and positive work ethic

QUALIFICATIONS

•   Bachelor’s Degree preferred
•   Minimum of six (6) years of Clinical Data Management experience
•   Proficient knowledge of CDISC CDASH and CDISC SDTM standards/guidelines
•   Experience performing medical coding and knowledge of MedDRA and WHODrug coding practices, preferred
•   Proficient knowledge of GCP, ICH and FDA guidelines
•   Advanced computer skills in Microsoft Word, Excel, PowerPoint, and Project
•   SAS experience preferred but not required
•   Experience with data management budgeting, forecasting and reporting

Excellent salary and benefits package offered.

For more information about Ionis and to apply for this position, please click Apply Now. Reference Requisition #17-0057

NO PHONE CALLS PLEASE. PRINCIPALS ONLY.

Ionis Pharmaceuticals, Inc. is proud to be an EEO employer.