Clinical Data Manager, Consultant

Scotts Valley, CA 95066
Full-time
Salary: $110,000.00 to $120,000.00 /year


Emanate is a data management consulting firm that focuses on start-up biotech companies. Most of our clients have between one to three ongoing studies conducting in Phase 1 / 2 that are outsourced to CROs.

We typically function as a member of the sponsor team. We make data management decisions on the sponsor’s behalf. We are responsible for communicating DM requirements to the CRO DM team. We may even participate in Data Management RFP.

As a CDM Consultant, you will be the primary point of contact supporting between 1 – 3 clients.

At study start-up, we act on behalf of our client working directly with their CRO on:

1. Setting up the EDC database set-up:

  • Review and Approve Screens and Edit Checks
  • Coordinating Sponsor UAT Approve
  • Database Go-live

2. Review and approve the data management plan

3. Review and approve CRF Completion Guidelines

4. Review and approve data transfer agreements

  • Central Lab
  • Biomarkers
  • Imaging Labs
  • Genomic
  • ECG

5. Guide set-up of IxRS, CTMS, Payments

6. Educate the Study team on DM Best Practices such as CDISC -CDASH.

7. Develop DM SOPs

During study conduct:

1. DM CRO Oversight

  • Data Cleaning Metrics
  • Clean Patient Trackers
  • CRO DM Performance Metrics
  • # of DM Queries issued over a month
  • Database Performance, i.e., are queries over-firing
  • Auditing if CRO DM is following Data Review Plan

2. Managing Sponsor Data Review / Medical Review

3. Work with CRO Clinical Programming Team for data cleaning outputs

4. Confirm data transfers and reconciliation is occurring per DTA agreements

5. Conducting/Monitoring SAE Reconciliation

6. Managing Interim Analysis, Safety Review Committee Meetings

7. Provide Data Entry Guidance to study team

During Database lock

1. Provide study guidance on activities required for database loc

Successful Characteristics

1. Technical Aptitude

  • Ability to read/write programming language as SQL, SAS, or R
  • Ability to use business intelligence tools
  • Intermediate to advanced skill level for excel
  • Understand Software development Life Cycle
  • Understand database designs

2. Project Management

  • Continually prioritize and reprioritize study deliverables in a fluid environment
  • Well Organized
  • Deliverable driven
  • Problem Solver – ability to take information and see potential issues and mitigate them.

3. Communication

  • Ability to explain technical concepts to a non-technical person
  • Ability to read non-verbal communications and adjust accordingly
  • Ability to teach team members
  • Written Communication
  • Ability to work in a high pace environment, with changing priorities

Education

Bachelor’s or Master’s degree

  • Computer Science / Applications / Technology /Information Systems
  • Mathematics / Statistics

Experience

1. At least eight years of clinical data management experience

2. Experience running clinical trials outsourced to a CRO as well as managed in-house

3. Knowledgeable in GCP, CDISC standards

4. Knowledgeable in Clinical TrialTechnologies

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