Senior Clinical Data Manager

Department: Clinical Operations
Date: 4/10/19
Reports to: Vice President, Clinical Operations


Position Summary:

Reporting to the Vice President, Clinical Operations, the Sr. Clinical Data Manager is responsible for overseeing and supporting data management at the CROs on multiple clinical trials and ensuring that data management objectives are met in accordance with clinical timelines, requirements, and quality standards.  S/he is responsible for all aspects of the data management process from study start-up through database lock for individual protocols; will act as the primary contact on all Data Management study-specific issues; will organize the data cleaning efforts with the internal study team and participate in data review; will act as internal consultant for clinical data management tools, standards and practices.

At the departmental level, the Sr. CDM will contribute to the development and revision of relevant SOPs and internal processes.  The Sr. CDM will formulate recommendations to Clinical Operations leadership on complex and important problems as they arise.  The Sr. CDM will take on a leadership role by acting as a resource and providing mentorship to less experienced colleagues.


General Responsibilities and Required Skills:

  • Displays highly developed leadership qualities

  • Possesses a comprehensive understanding of Data Management particularly as it relates to Drug Development

  • Expert on data requirements for assigned protocols

  • Proactively seeks out and recommends process improvements

  • Proven track record of anticipating potential data management issues within a study and program and preparing contingency plans with minimal oversight

  • Communicates clearly and effectively with internal and external key stakeholders

  • Routinely mentors junior staff; takes a leadership role in onboarding new personnel

  • May contribute to Clinical Development Plans with some oversight

  • Escalates issues in a timely and appropriate manner

Role & Responsibilities:

  • Oversee data management activities performed by CROs and other related vendors; ensure vendors meets timelines and objectives with quality data deliverables

  • Manage database building activities, including review and design of case report forms, data management plans, completion guidelines, edit check specifications, external data transfer specifications, and other study documentation prepared internally or by external vendors

  • Perform pre, during, and post-data entry review of clinical data, identify data discrepancies and corresponding resolutions, and generate and manage queries and data reconciliation on clinical trials

  • Review and provide feedback for key documents and processes such as data management plans, eCRF completion guidelines, internal data review plans, study metric reports, reconciliation plans, and medical coding plans

  • Plan and oversee execution of User Acceptance Testing

  • Design Electronic Data Transfer Specifications

  • Manage preparation of clean databases, including reviewing responses to queries for appropriateness, resolving any discrepancies, and modifying the database accordingly

  • Ensure study compliance with SOPs and regulations and develops study-specific training for internal and external study team

  • Review clinical study protocols and provide input

  • Review vendor RFIs, RFPs, proposals, and contracts and provide input

  • Manage data deliverables for NDA submissions

  • Prepare and deliver presentations at internal and external meetings

  • Evaluate and mitigate risks to timelines and quality

  • Work collaboratively with the study teams

  • Communicate clearly and effectively with internal and external stakeholders

Other:

  • Provide input regarding project resource requirements

  • Active participation in inspection readiness activities

  • Contributes to the development and continuing process improvement of relevant SOPs and internal processes

  • Additional responsibilities as assigned

Minimum Qualifications:

  • Bachelors’ degree in scientific/clinical related discipline, Masters or equivalent preferred, with at least 5 years of relevant work experience in a pharmaceutical or biotechnology environment

  • Comprehensive knowledge of industry standards for data, including ICH guidelines, GCP, CDISC, and other applicable regulatory guidelines as they pertain to data management

  • Functions independently with minimal oversight and willing to “wear many hats”

  • Strong written and verbal communication, organizational, and interpersonal/team skills

  • Proficient in MS Excel, Word and PowerPoint

  • Demonstrated experience with Electronic Data Capture (EDC)

  • Excellent time management skills, ability to organize and prioritize workload, attention to detail, and demonstrated ability to multi-task

  • Strong critical thinking and problem-solving skills

  • Familiarity with SAS as well as expertise in Medidata Rave or another modern EDC system

Preferred Qualifications:

  • 6+ years of relevant industry experience

  • Effective problem-solving skills

  • Knowledge of MS project

  • Small pharma experience 

  • Experience with pain or CNS trials

  • Experience with the implementation of industry standards (CDISC, CDASH and SDTM)

Work Environment: Office
Physical Demands: Occasional overnight travel

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily within the context of the representative work environment and physical demands described above.  Likewise, qualifications listed are representative of the knowledge, skills, and abilities required to perform the position’s essential functions.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability or protected veteran status.

To apply, please send an email with your resume and cover letter to hr@neurobopharma.com.