Clinical Data Manager !!, gene therapy

Location
Cambridge, MA, United States
Posted
Oct 22, 2018
Ref
1240431
Hotbed
Genetown
Required Education
Bachelors Degree
Position Type
Full time
Clinical Data Manager II

Join bluebird bio's enthusiastic and collaborative team by contributing to the overall success of our novel gene therapy approach.

The Clinical Data Manager II is responsible for leading moderate complexity clinical studies from study start-up to close out according to the study protocols, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements.

Responsibilities:

• Leads all the study-specific CDM tasks performed by the CROs for multiple moderate complexity studies
• Forecasts timelines and resources required to complete study-specific tasks on time and with high quality
• Leads execution of CDM tasks according to the agreed upon timelines, mitigating risks as appropriate
• Effectively delegates tasks to the CDM team members and vendors
• Plans and facilitates internal and external study meetings
• Authors Data Management Plans, Vendor Management plans, Cross-functional data review plans, eTMF maps, and other CDM documents in collaboration with other functions
• Collaborates with vendors and cross-functional teams to develop Data Transfer Specifications
• Authors and reviews operational clinical study documentation including project timelines, meeting minutes, memos and study notes to file
• Ensures that delegated and outsourced tasks are performed according to quality standards
• Performs all the data management tasks in support of Phase I - IV gene therapy clinical studies
• Reviews clinical protocols and provides input
• Leads eCRF design and Data Validation specifications programming
• Ensures that study documentation is filed according to SOPs and Work Instructions; leads QC of study files for completeness and accuracy
• Facilitates cross-functional data review for assigned studies
• Generates and analyzes study metrics and informs cross-functional study teams
• Leads development of eCRF Completion Guidelines
• Leads Medical Coding for assigned studies
• Leads User Acceptance Testing for clinical study databases
• Leads development of data reports for assigned studies
• Leads data review for accuracy, completeness, and consistency and performs QC of queries as appropriate
• Leads SAE reconciliation process
• Represents CDM at the cross-functional study team meetings, providing status updates, data trends, and risk mitigation strategies
• Adheres to study timelines and quality standards
• Manages time effectively; able to prioritize tasks and forecast task completion durations
• Participates in process development
• Assists in the development of data management standards
• Presents eCRF training to clinical study teams, sites, and CRAs at Investigator meetings.
• May mentor new and more junior team members

Knowledge, skills, and abilities required:
• Has in-depth CDM knowledge and basic understanding of related Clinical Development functions, typically developed from experience leading initiatives with a broad impact.
• Recognized as a technical/ professional expert direct escalation pathway within CDM.
• Solves complex problems and takes a broad perspective to identify solutions and best practices.
• Works independently, seeking guidance in very unique and complex situations.
• Proven ability to successfully design, lead and execute CDM initiatives with a clear positive impact on organizational goals.
• Participates in CDM goal setting as a subject matter expert.
• Must be able to work in a fast-paced environment with changing priorities and deadlines
• Highly organized and detail oriented
• Able to manage time effectively and prioritize
• Demonstrated experience in writing professional correspondence and clinical study documentation
• Strong EDC skills, including Medidata Rave and IBM Health
• GCP knowledge
• Therapeutic Area knowledge
• CDISC knowledge
• Strong understanding of clinical trial data
• Project management and delegation skills
• Strong communication skills

Education/Experience:
• Bachelor's degree, preferably in health science or related field