- Contribute to the strategy and development of the Clinical Data Management Systems to ensure data quality in support of clinical study data milestones and deliverables
- Contribute to the establishment systems and processes to help ensure clinical data security and integrity
- Interact and manage relationships with other functional areas to ensure high quality data management activities
- Oversee all aspects of clinical data e.g. EDC and safety database management, data reconciliation, CRF and safety form design, etc
- Standardize and manage the clinical data flow process to data delivery for analysis purposes
- Lead and/or contribute to standardization and process improvement initiatives
- Oversee and/or contribute to the process to identify, evaluate and select external business partners and technology vendors
- Manage for budget and resource planning across assigned projects
- Oversee CRO or FSP data management study personnel; Serves as an escalation point and resource for internal/external team; motivates and inspires CRO and FSP partners to deliver their best work
- Recruit, train, and manage employees and consultants within area of responsibility; Sets training standards
- Perform other work-related duties as assigned
- Apply innovative approaches into drug development
- BA/BS or equivalent degree with 10+ years of clinical data management experience in biotechnology or pharmaceutical industry, with outsourced CRO oversight experience
- Minimum 6-8 years of Electronic Data Capture (EDC) experience
- Must have advanced knowledge of Data Management processes and systems
- Solid understanding of clinical drug development processes required
- Solid understanding of CDISC standards required
- Solid understanding of ICH, GCP, 21 CFR Part 11 required
- Data visualization software (such as Spotfire) experience preferred
- Embodies Cytokinetics values; exhibits high degree of integrity and professionalism when interacting with outside investigators and vendors
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Associate Director, Clinical Data Management - South San Francisco, United States - Cytokinetics, Incorporated
Description
Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which cardiac muscle performance is compromised.
As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact myocardial muscle function and contractility.
We view our employees as the unequivocal ingredients to success.Each and every employee is an integral member of the Cytokinetics team, contributing to our shared goal of improving lives.
While expectations of our employees are high, there is an equal commitment to ensuring that contributions are recognized and rewarded.
We seek exceptional individuals to join us in our mission to develop potential medicines to improve the health span of people with cardiovascular and neuromuscular diseases of impaired muscle function.
As the Associate Director, Clinical Data Management (CDM), you will be is responsible for supporting the leadership of CDM across multiple drug development programs including the development and implementation of data standards based on CDASH/SDTM, CRO/FSP CDM oversight, developing CRO partnerships.
You will apply a comprehensive knowledge of data management platform, clinical trial databases, and industry standard process to optimize data quality and clinical trial efficiency.
This role will also see you contribute to all aspects of clinical data handling strategies, with focus on data integrity and global data regulatory compliance.
This position is a chance to have an impact on the future of Cytokinetics and help us continue to grow You will pair closely with the biometrics, IT, QA, CQA, Clinical Research, Clinical Operations, and Drug Safety to ensure compliance with policies, procedures, and overall clinical objectives.
Our passion is anchored in rigorous and diligent scientific and clinical approaches to the discovery and development of novel mechanism therapeutics.
With gratitude for the commitments and convictions of our employees who are inspired by the courage of patients we aim to serve, we believe Cytokinetics will continue to be a pioneering, values-driven, sustainable, fully integrated biopharmaceutical company.
Actual salary at the time of hire may vary and may be above or below the range based on various factors, including, but not limited to, the candidate's relevant qualifications, skills, and experience, as well as the service line and location where this position may be filled.
$189,000-$231,000 USD
Our employees come from different backgrounds, and we celebrate those differences.
We are looking for the best candidates for our open roles, but do not expect applicants to meet every qualification in order to be considered.
If you are excited about what you could accomplish at Cytokinetics and believe you can add value to our team, we would love to hear from you.
Please review our General Data Protection Regulation (GDPR) policy PRIOR to applying.Our passion is anchored in robust scientific thinking, grounded in integrity and critical thinking.
We keep the patient front and center in all we do - all actions and decisions are in service of the patient and their caregivers.
We champion integrity, ethics, doing the right thing, and being our best selves.Please visit our website at:
Cytokinetics is an Equal Opportunity Employer
Associate Director, Clinical Data Management professionals in South San Francisco
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Kuo-Ching Chang
Data Scientist