AD Clinical Operations

Lexington, MA

Associate Director, Clinical Operations 1121473

Job Scope & Purpose:

Our client is quickly growing and seeking an experienced Associate Director, Clinical Operations to join an impressive, cohesive team focused on treating patients suffering from hematologic and musculoskeletal disorders with high unmet medical need! This position is responsible for developing and implementing operational strategy at the program and study level and delivering clinical studies to time, cost and compliance/data quality goals. In addition, you will evaluate and oversee vendors across a wide array of development functions including project management, site monitoring, medical writing, biostatistics and clinical supplies.

Primary Job Responsibilities:

  • Program level clinical leadership as member of the Program Team responsible for representation of clinical objectives, cross-functional considerations and strategic clinical operations planning to meet company objectives.
  • Development of clinical development plans from both a strategic and operational perspective including leading the team through decision evaluation, timeline scenarios, risk assessment and financial planning.
  • Oversight of the development of clinical documents including investigator brochures, protocols, safety updates, and clinical study reports.
  • Develop approaches to indication and study feasibility including interactions with key scientific leaders and leveraging disease and study feasibility services of vendors.
  • Utilize outputs to determine appropriate geographies for clinical studies.
  • Evaluate, determine and implement the clinical vendor approach for studies; evaluate and select vendors, develop scopes of work and contribute to budget negotiations across vendor contracts.
  • Manage and oversee clinical vendors.
  • Oversee the delivery of clinical studies.
  • Develop and manage risk mitigation plans.
  • Ensure Good Clinical Practice and inspection readiness across studies including complete documentation and trial master file throughout a study.
  • Manage study and program budgets.
  • Ensure effective clinical and safety data review plans are developed and followed throughout the study.
  • Develop and oversee implementation of corrective actions to support good data quality.
  • Contribute to process development.

Primary Job Requirements:

  • BA/BS in a clinical or scientific discipline; at least 8 years of clinical operations experience (at least 5 of which have been working with a biotech/pharmaceutical company managing clinical studies).  Additional experience in other related fields or positions is a plus. 
  • Phase 2/3 global clinical study experience required.
  • Understanding of FDA, EMEA, ICH and GCP regulations and guidelines.

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.