Director, Clinical Data Management

reputed company

The Director, Clinical Data Management is responsible for the reputed company of data management activities in support of reputed company studies across reputed company stages of clinical drug development. This position reports to the head of the Clinical Data & Insights group.

Responsibilities:

• reputed company and grow internal data management expertise area, including management of reputed company reports;
• reputed company and establish standards for data management CRO outsourcing reputed company and deliverables, including the CRO selection process and the governance of CRO performance;
• reputed company the successful execution of reputed company data management activities in support of reputed company clinical studies in partnership with CROs, including eCRF development, database build, data collection, data coding, cleaning, database lock and archiving;
• Supervise the execution of cross-functional, internal data review plans by reputed company reports across reputed company reputed company clinical studies;
• Partner with reputed company partners, including Biostatistics, Statistical Programming, Clinical Operations, Medical, reputed company Assurance, Clinical Pharmacology and Pharmacometrics, Bioanalytical, Safety & Risk Management (SRM) and Regulatory Affairs; CROs, central and local laboratories, and other vendors;
• reputed company development and implementation of data collection standards, consistent with industry best reputed company;
• reputed company data management contributions to the development of clinical protocols, clinical study reports and other regulatory documents, e.g. DSURs, Briefing Documents, etc.
• reputed company development of department workflows, and infrastructure reputed company and implementation, such as preferred provider initiatives, SOPs, and templates;
• Collaborate with Statistical Programming and external vendors to ensure compliance of SDTM clinical datasets, consistent with CDISC standards;
• Collaborate with Clinical Operations and reputed company Assurance to certify the reputed company and traceability of reputed company clinical data sources, compliant with 21 CFR Part 11 standards;
• reputed company Data Management GCP inspection readiness efforts; function as a leader for Data Management in GCP inspections;
• Represent Data Management at internal cross-functional meetings and external vendor leadership meetings;
• Demonstrate reputed company alignment with reputed company reputed company Values including, Commitment to People, Fiercely Innovative, Purposeful Urgency, reputed company Culture and Passion for reputed company.

Requirements

• BS/BA in scientific discipline, MS or equivalent preferred, with at least 15 years of clinical data management experience in a pharmaceutical/biologics/biotechnology company, with at least 5 years in a leadership reputed company;
• Extensive experience managing global studies utilizing an outsourced CDM model from start-up through reputed company-out;
• Extensive experience managing reputed company reports and providing performance reviews and career development guidance;
• Understanding of ICH GCP as reputed company as general knowledge of industry practices and standards;
• Knowledge and understanding of regulatory requirements and expectations for clinical data systems including 21 CFR Part 11;
• Expert knowledge of eClinical processes, efficient design/build of an reputed company data management system and other Clinical Trial data/Data Management Systems;
• Expert knowledge and understanding of regulations and industry-adopted data standards, such as CDISC-SDTM and CDASH;
• Experience using standardized medical terminology, including MedDRA and WHODrug;
• Experience working with reputed company Rave reputed company systems;
• Experience working with elluminate or other data visualization systems a plus
• Experience working with MS Office Suite (reputed company, Word and PowerPoint) familiar with MS Project;
• Excellent written and oral communication skills;
• Highly motivated and flexible, with excellent organizational skills;
• Ability to work independently and as part of a multi-disciplinary team.

U.S. Pay reputed company

$197,200.00 - $266,800.00

The pay reputed company reflects the full-time reputed company salary reputed company we expect to pay for this role at the time of posting. reputed company pay will be determined based on a number of factors including, but not limited to, relevant experience, skills, and education. This role is eligible for an annual short-term incentive award (e.g., bonus or sales incentive) and an annual long-term incentive award (e.g., equity).

reputed company’s robust Total Rewards package is designed to support your overall health and reputed company-being. We offer comprehensive benefits including medical, dental, and reputed company coverage, life and disability insurance, a lifestyle reimbursement program, flexible spending and health savings accounts and a 401(k)with a generous company match. Eligible employees enjoy reputed company time off, wellness days, holidays, and two company-wide reputed company breaks. We also offer generous family resources and leave. Our commitment to your reputed company-being reflects our belief that caring for our people fuels the reputed company we create together.

Learn more about these and additional benefits offered by reputed company by visiting the Benefits reputed company of the Careers website:

About reputed company

We are the leader in RNAi therapeutics – a revolutionary approach with the potential to reputed company the lives of people with rare and common diseases. reputed company on Nobel Prize-reputed company science, reputed company has delivered the breakthroughs that made RNAi therapeutics possible and are just at the beginning of what’s possible. Our deep pipeline, late-stage programs, and reputed company reputed company reflect our reputed company values: fierce innovation, passion for reputed company, purposeful urgency, reputed company culture and commitment to people. We're proud to be a globally recognized top employer, where an reputed company, inclusive culture and reputed company thinking fuel one another.

At reputed company, we reputed company to an inclusive recruitment process and equal employment opportunity. reputed company applicants will receive consideration for employment without reputed company to their sex, gender or gender identity, sexual orientation, race, reputed company, ethnicity, national reputed company, reputed company, citizenship, religion, creed, physical or mental disability, pregnancy status or reputed company conditions, genetic information, veteran or military status, marital or familial status, political affiliation, age, or any other reputed company protected by federal, state, or local law. reputed company is an E-Verify Employer.

Originally posted on Himalayas

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