Senior Manager, Clinical Operations

Cambridge, MA

Senior Manager, Clinical Operations1114788

Job Scope & Purpose:

Our client is a Global biotech company building a presence in Boston and seeking an experienced Sr. Manager, Clinical Operations to join a growing team!  The position will initially focus in metabolic clinical development, enjoy a great deal of autonomy under strong leadership, and allow an ability to make a significant impact.  The successful candidate will be a resourceful, problem-solving, integrative thinker for the role of supporting clinical development projects across all phases (pre-IND through Phase 1-4). This key role will support strategic planning as well as clinical study execution by managing timelines, project budgets, and oversee day to day activities for out-sourced activities. 
 
Primary Job Responsibilities:

  • Oversight of the operational aspects of all stages of clinical studies: create, manage, and oversee clinical operations programs, including operational study management, study budget and timeline control
  • Coordinate the evaluation, selection and management of Contract Research Organizations (CROs) and other external vendors to ensure successful clinical trial implementation and execution
  • Liaise with clinical site staff and Investigators as appropriate to ensure optimal Sponsor-site relationships
  • Develop and drive patient recruitment programs that deliver enrollment targets
  • Assist with the authoring of development plans, clinical study protocols, informed consent forms (ICFs), clinical study reports (CSRs) and other clinical documents as necessary
  • Co-monitor studies as necessary
  • Support the preparation of regulatory filings (e.g. pre-IND, IND, orphan applications, etc) as needed
  • Partner with CMC/clinical supplies to ensure drug supply assumptions are met, while contributing to the design and packaging of supplies for clinical trials, as needed
  • Plan and coordinate study meetings, vendor meetings and clinical Investigator meetings as needed
  • Support the interaction with external experts in the medical and scientific community for scientific consulting and for advisory boards

Primary Job Requirements:  

  • Bachelor’s degree in a scientific or healthcare discipline and experience in clinical and drug development in the pharmaceutical/biotech or related industry and have a deep understanding of Clinical Development 
  • Understanding of drug development from pre-IND through NDA 
  • Acquired knowledge or practical experience in metabolic diseases (e.g. Diabetes mellitus, NAFLD or NASH) and immuno-oncology
  • Knowledge of regulatory requirements, Good Clinical Practices, FDA regulations, and relevant ICH guidance documents  
  • Experience managing clinical programs, CROs, budgets, and timelines
  • Experience in monitoring clinical studies and conducting PSVs, SIVs, IMVs, and COVs will be considered favorably
  • Knowledge of MS Project and/or other project management software with an ability to maintain and track KPI’s

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.