Remote Clinical Manager - CRO management, budgets

Apex Life Sciences Fort Worth, TX

Responsibilities:

  • Apply knowledge of health care and clinical data and database management to contribute to clinical trial program in support of Clinical Trial Head, to assure deliverables are met for assigned trials according to timelines, budget, operational procedures and quality standards.
  • Support all aspects of clinical trials (phase I-IV, Expanded Access, Investigator initiated and Compassionate use and registries as assigned) and program level activities as required.
  • Develop specific sections of protocol, study tools, guidelines and training materials.
  • Accountable for accuracy and timeliness of trial information in all trial databases and tracking systems.
  • Responsibilities include management of clinical study material; implementation of issue resolution plan; preparation of clinical outsourcing specifications. Contribute to ongoing scientific review of clinical data and generate queries in OC RDC database.
  • Support trial data analysis, reporting and publishing
  • Contribute to development of Case Report Forms (CRFs), edit checks, CRF completion guidelines, data review reports and trial statistical analysis plan in collaboration with trial data manager, trial statistician, statistical programmer and clinical development representative.
  • Act as point of contact for all site-related issues and procedural questions. Conduct Clinical trial team meetings and take meeting minutes as required. Contribute to defining Data Review Plan; participate in data review as specified in the Data Review Plan.
  • Manage interactions with relevant line functions including data management, drug supply management, clinical development, and statisticians, medical.
  • Ensure timelines, budget, operational procedures and quality standards, SOPs and Business Guidance are met for all assigned trial deliverables.
  • Apply knowledge and experience in clinical research process and compliance with GCP, FDA regulatory reporting requirements, IND, NDA and 21 CFR Part 11 guidelines as required.
  • Assist with program level activities such as development of clinical sections of regulatory documents, including Investigators' Brochures, briefing books, safety updates, IND/NDA submission documents.
Qualifications:
  • Bachelors degree with 9 to 13 years experience required.
  • Masters degree in Science with 7 to 11 years experience preferred
  • 7+ years of experience in Drug/Device Development.
  • Solid understanding of the integrated development process of devices or pharmaceuticals.
  • Understanding of the disease (project specific), natural course, standard of care and expected (reported) treatment outcome.
  • Knowledge of disease specific clinical efficacy and safety endpoints.
  • Logical thinking. Some experience in writing clinical protocols.
  • Sufficient disease (project specific) and treatment knowledge to identify critical data.
  • Scientific thinking allowing to identify bias and validity issues.
  • Experience in understanding impact of results on studies.
  • Multiple years of experience in running multinational clinical studies independently without significant supervision.
  • Ability to proactively identify issues and respond appropriately.
  • Solid understanding of the regulations (FDA, EMA, ICH, ISO etc.).
  • Organizational awareness to operate in a cross-functional team.
  • Communicates effectively to provide clear directions of what has to be done.
  • Builds support from others in situations with no direct authority.
  • Ability to embrace and communicate change.
  • Well organized; solid project management skills.

**Remote candidates will be considered

***For immediate consideration, please email your updated resume to [Click Here to Email Your Resumé] with 'Remote Clinical Manager' in the subject line.

EEO Employer

Apex 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. 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 [Click Here to Email Your Resumé] or 844-463-6178.