Senior Clinical Data Manager

Job Description

Job Title:             Senior Clinical Data Manager

Reports To:          Vice President Clinical Operations

Location:               Boston, MA

Position Summary:

Reporting to the Vice President, Clinical Operations, the Senior Clinical Data Manager will be responsible for establishing and managing the data management function through management of existing CRO partners performing data management activities across multiple programs and therapeutic indications.

Key Duties and Responsibilities:

  • Seek to have a profound impact on young children and their families
  • Potentially be part of the first launch of a medicine for a rare pediatric liver disease
  • Work on a portfolio of multiple potential therapies
  • Gain a rare diversity of commercial experience
  • Develop strategy, as well as manage execution
  • Help shape the culture and future of an emerging biopharma with a big vision
  • Collaborate with a small, collegial team of good people
  • Learn from leadership with deep experience and a history of success
  • Be part of an early biopharma company in an excellent financial position
  • Enjoy great work/life balance, including flex hours, ability to work remotely on Friday’s, generous holiday schedule and business-casual work environment

Responsibilities (may vary): This description is not intended to provide an all-inclusive listing of duties and responsibilities. Duties may change at the discretion of management, and/or management may request duties be performed that are not listed. This job description is not a contract of employment and does not change your status as an at-will employee.

Key Duties and Responsibilities:

  • Oversee the establishment and maintenance of Data Management plans and study-specific data quality related documents;
  • CRF Development and EDC validation including edit specification development and validation;
  • Provide oversight of external partners (e.g. CDM CROs, central laboratories, ECG core labs, dictionary coding service providers, etc.) to ensure consistency and quality are maintained across projects;
  • Ensure that clinical data management activities for clinical trials and regulatory submission projects are completed on time and with excellent quality;
  • Ensure the delivery of clinical trial databases of the highest quality by establishing procedures for ongoing and final data review;
  • Ensure that CDM study files are organized and accessible during study conduct, and that archives are completed after study closeout;
  • Author and review department SOPs, as needed
  • Mentor junior department team members

Qualifications:

  • Bachelor’s degree in a scientific, medical or related field; at least 7 years of experience in clinical data management, in pharma/biotech
  • Thorough understanding of clinical trials process and regulatory requirements;
  • Thorough understanding of core CDM processes and procedures generally adopted as best practices within the industry, including knowledge of CDM processes with safety laboratory data management and dictionary coding for adverse events and medications;
  • Fully adept at the mechanics of conducting all phases of clinical trial data management within electronic data capture databases;
  • Familiar with the regulations that govern CDM activities;
  • Excellent organizational skills and able to adapt to multiple priorities in a fluid environment;
  • Excellent verbal and written communication skills;
  • Excellent skills in validating EDC databases and performing data review;
  • Demonstrated leadership ability and project management skills;
  • Experience managing CROs in data management-related activities;
  • Ability to use PC and widely used software packages, e.g., Excel, MS Word, SAS programming

JOIN ALBIREO

Equal Opportunity Employer

Albireo Pharma, Inc. is an equal opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.

All applicants should be legally entitled to work for any employer in the U.S.

Note to employment agencies: Please do not forward any agency resumes.  Albireo is not responsible for any fees related to resumes that are unsolicited.