Senior Manager, Clinical Data Management

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Apex Systems
Manager, Management, Development, Testing, PC, Excel, SAS, Systems
Full Time

Job Description

Senior Manager, Clinical Data Management 1181665

Job Scope & Purpose:

Our client is a clinical-stage pharma company focused on treating liver disease. They seek a talented CDM to be responsible for establishing and managing study data management activities through management/oversight of CRO partners performing data management activities across multiple clinical programs and therapeutic indications.

Primary Job Responsibilities:
  • Oversee the establishment and maintenance of Data Management plans and study-specific data quality related documents across all data systems (e.g. EDC, IXRS, lab, eCOA, etc.)
  • CRF Development and EDC validation including edit specification development and validation and User Acceptance Testing across all data systems
  • Serves as the DM focal point on assigned studies for all local interfaces and preserves a fluent workflow with the other interfacing departments and local procedures and processes
  • Provide oversight of external partners (e.g. CDM CROs, central laboratories, ECG core labs, dictionary coding service providers, etc.) to ensure consistency and quality are maintained across projects
  • Manage the team data review and ensure all data issues are resolved per expectations for the delivery of clinical trial databases of the highest quality.
  • Provide oversight of data transfer and/or data integration agreements across external data sources.
  • Ensure that clinical data management activities for clinical trials and regulatory submission projects are completed on time and with excellent quality;
  • Ensure that CDM study files are organized and accessible during study conduct, and that archives are completed after study closeout.
  • Author and review department SOPs, as needed
  • Mentor junior department team members, as needed

Primary Job Responsibilities:
  • Bachelor's degree in a scientific, medical or related field; at least 7 years of Lead clinical data management experience, in pharma/biotech
  • Thorough understanding of clinical trials process and regulatory requirements
  • Thorough understanding of core CDM processes and procedures generally adopted as best practices within the industry, including knowledge of CDM processes with safety laboratory data management and dictionary coding for adverse events and medications
  • Fully adept at the mechanics of conducting all phases of clinical trial data management within electronic data capture databases from study start up to study close out
  • Familiar with the regulations that govern CDM activities
  • Excellent organizational skills and able to adapt to multiple priorities in a fluid environment
  • Excellent verbal and written communication skills
  • Excellent skills in validating EDC databases and performing data review;
  • Demonstrated leadership ability and project management skills
  • Experience managing CROs in data management-related activities
  • Ability to use PC and widely used software packages, e.g., Excel, MS Word, SAS programming

About Stratacuity:

Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.

PROVEN SCIENTIFIC PLACEMENT™

Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us.

jprice@stratacuity.com

Code: ClinOps

EEO Employer

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.


Company Information

Apex Systems is a world class technology services business that incorporates industry insights and experience to deliver solutions that fulfill our clients’ digital visions. We provide a continuum of service from workforce mobilization and modern enterprise solutions to digital innovation to drive better results and bring more value to our clients. Apex transforms our customers with modern enterprise solutions tailored to the industries we serve. Apex has a presence in over 70 markets across US, Canada and Mexico. Apex is a segment of ASGN Inc. (NYSE: ASGN)

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Dice Id : apexsan
Position Id : BHJOB2374_1181665
Originally Posted : 2 months ago

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