Clinical Research

Associate Director, Clinical Data Management Direct Hire MA

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Job ID: 16113 Direct Hire MA

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Associate Director, Clinical Data Management

Our Cambridge, MA client targets serious diseases and they are seeking an experienced, highly-motivated Associate Director level candidate to lead their Clinical Data team! You will collaborate with and help other teammates to adhere to study protocols, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements. The main function of this role is to monitor all activities of Phase 1-3 Clinical trials and to oversee contract and junior team members. 

  • Lead a team through daily activities as well as the oversight/management of extended projects
  • Participate in the development of database standards and ensure that when CROs perform data management activities that they adhere to these standards
  • Review clinical database-related output and deliverables produced by CROs on an ongoing basis to provide technical and business expertise
  • Ensure that all clinical data received and processed are completed and accurate for all parameters required by the study protocols in collaboration with cross-functional colleagues.
  • Understand and maintain documentation that SOPs are followed for CDM
  • Oversee CROs in their delivery of data management milestones

Requirements:

  • Bachelor of Science degree preferred, preferably in health related field and computer science
  • 8+ years’ experience in clinical data management in the pharmaceutical and biotechnology
  • Experience in all phases of data management for clinical trials is preferred
  • Knowledge of GCP, regulatory and ICH Guidelines as applicable to data management
  • Must be on-site in Cambridge office 4 days/week

Formal descriptions can be supplied for interested candidates.

Must be authorized to work in the US to be considered and must be commutable to the Cambridge area or able to relocate with limited assistance. 

All resumes will be kept strictly confidential until you choose to pursue a specific opportunity with one of our clients.

Clinical Data Management II Direct Hire MA

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Job ID: 16089 Direct Hire MA

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Clinical Data Manager II

Summary: Ensure quality and timely clinical data delivery from start to close out. Establish appropriate application of data standards and perform quality assurance review of key clinical data management (CDM) deliverables.

Responsibilities:

• Monitor clinical data quality and progress of trials outsourced to CROs; drive corrective actions as needed

• Leads medical coding and the development of eCRF Completion Guidelines

• Ensure clinical databases are structured in alignment with case report forms and data standards

• Manages timelines and oversees quality standards

•  Performs all the data management tasks in support of Phase I – IV gene therapy clinical studies

• Develop CDM presentations for Investigator Meetings, CRA workshops, and Project Kick-off meetings as appropriate

• Facilitates cross-functional data review for assigned studies

Requirements:

• Bachelor’s Degree and 4 or more years CDM and/or clinical trial operations experience

• 2 or more years of experience in managing outsourced work or working for a CRO

• GCP knowledge

• EDC skills, including Medidata Rave and IBM Health

• Strong understanding of clinical trial data

• Ability to review high volumes of data for quality issues; attention to detail

• Organizational, planning and project management skills

• Interpersonal, communication, and negotiation skills

• Ability to operate effectively in a team environment

Associate Director, Clinical Data Management Direct Hire MA

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Job ID: 16039 Direct Hire MA

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Associate Director, Clinical Data Management

Our client is a highly-regarded cell/gene therapy company in the greater Boston area and they are seeking an experienced, highly-motivated Associate Director level candidate to lead their Clinical Data team! You will collaborate with and help other teammates to adhere to study protocols, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements. The main function of this role is to provide strategic planning and effectively manage external vendors and junior personnel.

  • Lead a team through daily activities as well as the oversight/management of extended projects
  • Participate in the development of database standards and ensure that when CROs perform data management activities that they adhere to these standards
  • Review clinical database-related output and deliverables produced by CROs on an ongoing basis to provide technical and business expertise
  • Ensure that all clinical data received and processed are completed and accurate for all parameters required by the study protocols in collaboration with cross-functional colleagues.
  • Understand and maintain documentation that SOPs are followed for CDM
  • Oversee CROs in their delivery of data management milestones

Requirements:

  • Bachelor of Science degree preferred, preferably in health related field and computer science
  • 8+ years’ experience in clinical data management in the pharmaceutical and biotechnology
  • Experience in all phases of data management for clinical trials is preferred
  • Knowledge of GCP, regulatory and ICH Guidelines as applicable to data management
  • For the best fit, you should be a results-oriented team player with strong interpersonal and communications skills, capable of working collaboratively with colleagues.  

Formal descriptions can be supplied for interested candidates.

Must be authorized to work in the US to be considered and must be commutable to the Cambridge area or able to relocate with limited assistance. 

All resumes will be kept strictly confidential until you choose to pursue a specific opportunity with one of our clients.