Clinical Data Manager

August 2, 2023
Share
  • Full Time
  • Anywhere
  • Applications have closed

Website May Health

Clinical Data Manager

May Health, formerly AblaCare, is a clinical-stage medical device company committed to developing treatment options for women living with PCOS. The company is currently investigating its Ovarian Rebalancing™ treatment in clinical studies; Ovarian Rebalancing is a novel approach to PCOS-related fertility that has the potential to be a safe, straightforward option for activating natural ovulation. May Health is led by a team of serial medtech and women’s health entrepreneurs and executives with extensive experience in product development, validation, and launch. The company has raised €10M in a Series A led by Sofinnova Partners and was founded in 2017 by the firm’s medtech acceleration team, Sofinnova MD Start. May Health is headquartered in Paris, France. For more information, visit www.mayhealth.com.

Position Summary

The Clinical Data Manager is responsible for leading, assisting, and providing operational support to all aspects of data management from study design through final database lock.

Responsibilities

Major Responsibilities:

  • Define and lead data management activities for multiple complex studies to deliver high quality data and meet the study milestone.

  • Define, develop and/or review creation of essential Data Management deliverables including data management plans (DMPs), Case Report Forms (CRFs), data transfer specifications, eCRF Completion Guidelines, training materials, and user aids, etc.

  • Collaborate with cross functional study team to ensure data management deliverables align to broader clinical project timelines, proactively escalating issues when appropriate.

  • Oversee the data monitoring/cleaning activities according to DMP (Data Management Plan), SOPs and regulatory requirements.

  • Ensure compliance of clinical data management process with applicable regulatory requirements.

  • Identify and make recommendations on trends in data discrepancies and remediation, including developing instruments (e.g., query reports, data review meetings), and training requirements across studies and therapeutic areas to ensure uniformity in approach and execution.

  • Collaborate with vendors and internal teams to define and develop integration (data & process) specifications for clinical trial database.

  • Develop and provide input on departmental processes and SOPs.

Compliance & Legal Responsibilities:

  • Maintaining the highest standards of ethics in all circumstances

  • Ensuring respect of Good Clinical Practices and General Data Protection Regulation Ensuring compliance with the Company quality system and all applicable guidance, standards and regulations.

Position Requirements

Necessary skills and experience:

  • Minimum of 5 years of data management experience working on regulated research studies, preferably with investigational medical devices.

  • Excellent planning, organizing, problem-solving, and execution skills with the ability to appropriately initiate and escalate.

  • Experience developing Case Reports Forms, Database Specifications, conducting UAT, and providing input into database development.

  • Experience training sites to eCRF and database use.

  • Strong Project Management skills.

  • Ability to communicate effectively to all levels of the organization and research partners (excellent written and verbal communication skills).