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Alira Health

Associate Director of Clinical Data Management

Remote Boston, MA
GCP
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Description

Join our global team dedicated to innovation and initiative, where physical walls and different time zones don’t limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others.

Job Description Summary

The Associate Director of Clinical Data Management leads and drives the DM team, acting as mentor and coach and as the reference point for the Sponsor and the appointed person responsible for the project from the Data Management perspective, to develop the data collection specification from all data sources. The Associate Director of Clinical Data Management manages in-stream data flow activities and deliver a quality database in accordance with the project plan, ensures DM tasks for the assigned studies are performed on time and within budget, makes recommendation for process improvement and/or new standards development. The Associate Director of Clinical Data Management is an effective input into strategic planning across the department and bridges scientific or medical knowledge to data management processes to ensure sound data collection tools, validations and integration to fit for purpose clinical datasets department .

Job Description

ROLE

The Associate Director of Clinical Data Management supports the Senior Director of Clinical Data Management in running the department efficiently, to appropriate quality standards and in line with company strategy. He/She supports commercial development of clinical data management department. The Associate Director of Clinical Data Management leads and drives the DM team, acting as mentor and coach and as the reference point for the Sponsor and the appointed person responsible for the project from the Data Management perspective, to develop the data collection specification from all data sources The Associate Director of Clinical Data Management manages in-stream data flow activities and deliver a quality database in accordance with the project plan, ensures DM tasks for the assigned studies are performed on time and within budget, makes recommendation for process improvement and/or new standards development. The Associate Director of Clinical Data Management is an effective input into strategic planning across the department and bridges scientific or medical knowledge to data management processes to ensure sound data collection tools, validations and integration to fit for purpose clinical datasets department.

KEY RESPONSABILITIES 

  • Define processes for DM tasks and ensure adherence and compliance 

  • Supervises the activities of the data management team in terms of technical aspects and pastoral care. 

  • Coaches and mentors DM resources on process and technical issues. Develops and updates data management processes based on systems used in the department. 

  • Present at external professional/industry organization meetings or conferences. 

  • Represent the DM function in meetings with sponsors (bid defence meetings, kick-off meetings etc.) 

  • Provides pastoral care to the DM team. 

  • Ensures compliance with ICH/GCP guidelines, applicable laws and regulations for all clinical studies. 

  • Supports the DM Director in identifying the resources needed to ensure the successful delivery of projects. 

  • Ensures that the team makes best use of all tools and techniques available.

  • Supports the DM Director in ensuring the alignment of team member objectives company strategy and objectives. 

  • Responsible for the development of the capabilities and skills necessary to meet current and future data management needs. 

  • Solves data quality issues that may arise in internal audits, assessments or inspections by sponsors or health regulatory authorities. 

  • May Contribute to the preparation of Budget Proposals.

  • Reports problems and critical issues to the direct superior.

  • Accountable for driving achievement of project milestones from study start up through to delivery of database in compliance with project budget.

  • Be primary contact for sponsor and internal project team for assigned studies.

DESIRED QUALIFICATION & EXPERIENCE 

  • Degree in life sciences, pharmacy, biology or related field or at least 10 years of experience in the data management field in a pharmaceutical or equivalent environment. 

  • Strong knowledge of GCP regulations and procedures 

  • Strong knowledge of Data Management processes 

  • Broad understanding of the pharmaceutical industry and the clinical development process 

  • Knowledge of study related regulations and guidelines relating data management and associated best practices 

  • Proficiency in Medidata Rave or Merative Zelta

  • Experience in oncology

TECHNICAL COMPETENCES & SOFT SKILLS 

  • English, Excellent 

  • Understanding of international cultures 

  • Ability to develop future plans and goals for the department 

  • Professional  

  • Trustworthy 

  • Ability to effectively prioritize 

  • Quality focused 

  • Personable Attitude 

  • Willingness to learn 

  • Team Player 

  • Effective Stress Management Techniques 

  • Learning Agility 

  • Ability to Manage Conflict  

  • Problem Solving Skills 

  • Effective Verbal Communication Skills 

  • Commercial and Technical Writing Skills 

  • Networking Skills 

  • Analytical thinking 

  • Resilient 

  • Ability to Influence and motivate 

  • Ability to manage difficult conversations 

  • Innovative 

  • Ability to Provide Constructive Feedback 

  • Excellent Presentation Skills 

  • Commercial awareness 

  • Ability to recognize and develop talent

    Languages

    English

    Education

    Bachelor of Science (BS): Biology, Bachelor of Science (BS): Life Sciences, Bachelor of Science (BS): Pharmacy

    Contract Type

    Regular
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    0 applies

    3 views

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