Clinical Data Manager

AllSTEM Connections; United States; Remote; USD 100,000 - 140,000; Full time

Job summary

A leading company in biotechnology is seeking a Clinical Data Manager to oversee project management and ensure quality control of clinical databases. This remote position involves collaboration with cross-functional teams to deliver key products while adhering to strict compliance regulations. Join to make a significant impact in the biopharmaceutical industry within a 12-month contract that could extend or lead to permanent employment.

Benefits

Medical insurance

Vision insurance

401(k)

Qualifications

• Experience in oversight of outside vendors (CROs, etc.).
• Experience working in a global matrix organization.
• Knowledge of FDA regulations and compliance guidelines.

Responsibilities

• Coordinate project level DM tasks and ensure timelines are met.
• Lead quality control checks and ensure databases are delivered.
• Communicate project level issues to stakeholders.

Skills

Excellent oral and written communication skills

Proven ability to lead and manage

Clinical research experience

Knowledge of Good Clinical Practices (GCP)

Strong interpersonal skills

Education

Degree in life science, computer science, or business administration

Job description

1 week ago Be among the first 25 applicants

Direct message the job poster from AllSTEM Connections

AllSTEM Connections is seeking a Clinical Data Manager to work remotely in any US time zone, i.e., PST/MST/CST/EST..

This is a 12-month contract position. Possible extension/temp-to-hire.

Hourly rate is up to $69.75/hour.

M-F, 8AM - 4PM.

SUMMARY:

Let’s do this. Let’s change the world. The Data Manager taking this role will partner with cross-functional study teams as well as the CRO partner to ensure product delivery of the Biosimilars portfolio. Biosimilars Data Management designs, plans, and implements the capture, cleaning and storage of all Company clinical study and trial management data and maintains the CRO partnership SharePoint sites.

RESPONSIBILITIES:

• Project level coordination and day-to-day oversight of DM tasks including: Review all DM documents within a project area to ensure a consistent approach and review of project timelines and metrics to ensure databases are delivered to set timelines.
• Ensure that quality control checks are occurring such that quality databases are delivered and batch cleaning SLAs are conducted as per contract.
• Review and approve study specific training and lead vendor results and relationship at the study level.
• Communication of project level issues including processes, timelines, resourcing, performance, etc.
• Review of all study level non-DM documents for awareness and project level consistency.
• Lead electronic submission activities and assist with response to questions and findings from Clinical Quality Assurance (Quality Assurance) and other audits at the study / vendor level.
• Lead or participate in the development, review and implementation of processes, policies, SOPs, and associated documents affecting DM.

QUALIFICATIONS:

• Degree in life science, computer science, business administration or related field.
• Clinical Data, Project, and Planning Management experience in the Pharmaceutical or Biotech industry.
• Experience in oversight of outside vendors (CRO’s, central labs, imaging vendors, etc.).
• Knowledge of relevant therapeutic or product area
• Clinical research experience obtained working on industry-sponsored global clinical trials
• Excellent oral and written communication skills
• Proven ability to lead, manage, and motivate others in a complex, multi-functional environment
• Experience working in a global, matrix organization on global clinical development programs
• Knowledge to represent and evaluate strategies for clinical development and to critically evaluate outside expert advice
• Broad knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and international regulatory requirements/guidelines
• Solid understanding of Biopharmaceutical/Healthcare Compliance
• Proven ability to anticipate and resolve problems
• Excellent interpersonal and organizational skills
• Professional collaboration and leadership skills
• Experience anticipating and resolving problems
• Experience writing and presenting clearly on scientific and clinical issues
• Experience collaborating and leading cross-functional teams
• Team leadership
• Strong written and oral communication

Seniority level

• Seniority level

  Associate

Employment type

• Employment type

  Contract

Job function

• Job function

  Research, Science, and Consulting

• Industries

  Biotechnology Research and Pharmaceutical Manufacturing

Referrals increase your chances of interviewing at AllSTEM Connections by 2x

Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

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