Director/AD Clinical Data Manager - Oncology

Arlington, MA

Director/AD Clinical Data Manager, Oncology 1109709 

Job Scope & Purpose:

Our emerging, oncology focused client is seeking a talented Director/AD, Clinical Data Manager to join a growing team for their portfolio of early stage assets.  The successful candidate will possess prior oncology experience and an ability to work in a fast-paced, dynamic environment.  The Director Clinical Data Manager will be responsible for the data management activities across a single clinical program or group of related studies, provides Clinical Data Management (CDM) leadership and expertise to project and study teams. Will have a good knowledge of the end to end clinical research and CDM processes, as well as global regulatory and industry rules and guidance (i.e. ICH, GCP) to support drug development processes and global project submissions through to approval. 

Primary Job Responsibilities:

  • Responsible for all aspects of the CDM process from study start up to database lock for Electronic Data Capture (EDC) trials
  • Represent CDM as the core Clinical Study Team member for all studies across a program and at Clinical Development Teams
  • Provide oversight for third party vendors, such as CROs and CDM technology solutions, by providing input on budgetary items, vendor selection and management, risk and communication management
  • Serve as the key Subject Matter Expert on topics related to CDM activities. Contributions include, but are not limited to: vendor selection and management, mentoring junior staff, developing process training and standard processes, training team members, leading or contributing to expert working groups, presenting Best Practices at internal and external industry meetings
  • Ensure adequate application of CDM Best Practices across studies within assigned program: review Clinical Study Team documents for project consistency; ensure the adequate documentation of all CDM activities according to SOPs
  • Provide feedback on draft protocols, Statistical Analysis Plans, Clinical Study Reports and other documents as required
  • Support the development and implementation of Program and Clinical Study CDM strategic initiatives and activities
  • Work with team members via matrix relationships (internally or at external service providers) by directing work, resolving problems and/or providing guidance
  • Perform duties in compliance with SOPs, GCP and ICH guidelines in accordance with regulatory, legal and ethical standards
  • Track and lead program-level CDM activities: ensures the timely delivery of high-quality study databases; identifies issues, define and direct resolution measures; reports progress and escalates issues into management
  • Develop robust and productive relationships with internal and external business partners: treats others fairly and with respect; manage conflicts constructively; provide timely and relevant feedback

Primary Job Requirements:

  • Bachelor’s degree in scientific or health-related field is preferred
  • Minimum of 5-7 years of experience in the pharmaceutical/biotechnology industry covering Phase I, II and III studies as a lead Data Manager within a Data Management organization
  • Advanced experience with clinical data collection, cleaning and analysis
  • Advanced experience in CRO and vendor oversight in fully outsourced models
  • Working knowledge of relational databases and at least one EDC system
  • Advanced knowledge of GCP/ICH standards, 21 CFR Part 11, CDISC requirements
  • Experience with pivotal clinical trials in Oncology preferred
  • Familiar with advanced concepts of clinical research and able to work effectively in a team/matrix environment

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

 

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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.