Manager, Project Data Management

Location
US;Homeworking
Salary
Competitive
Posted
17 Jun 2021
Closes
10 Jul 2021
Ref
2021-15306
Discipline
R & D , Scientific
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
Overview

A Manager, Project Data Management (Manager, PDM) is responsible for managing data review activities and staff to ensure all time frames and targets are met across the department. The Manager, PDM may also act as the Principal PDM or functional Project Manager across projects or programs.

Advanced Clinical is a global clinical development organization that provides CRO, FSP, Quality & Validation, and Strategic Resourcing services for biopharmaceutical and medical device organizations. Our mission is to deliver a better clinical experience for our clients. With global experience in over 50 countries, we are committed to improving all lives touched by clinical research. We understand the complex nature of the clinical research industry and approach each opportunity with compassion. Together, we answer the hopes of patients and healthcare professionals with industry-leading services in global life-sciences. As part of the Advanced Group family of companies, Advanced Clinical employees provide the support, structure, and professional background and experience for better clinical trials and research. They are the foundation of our energetic and collaborative environment, where constant learning and service to others take top priority. We seek dynamic, hard-working team members who are inspired to work amongst diverse backgrounds and perspectives. From our altruistic mission to outstanding career development opportunities, there's no better place to grow your career than Advanced Clinical.

Responsibilities

  • Managerial Responsibilities
    • Onboarding of new employees including training on data management procedures and systems.
    • Mentor, monitor, and supervise direct reports (including monitoring time reporting and training requirements).
    • Conduct performance reviews and assist with goal setting of direct reports.
  • Assist with resourcing assignments for Project Data Managers.
  • Act as the Principal Project Data Manager for assigned projects.
  • Act as Project Manager on standalone Data Management projects.
  • Responsible or project budget oversight, revenue recognition and forecasting, billing, invoicing, and generation of change orders.
  • Identify data management project issues and work with Senior Department Management on remedial action.
  • Assist in the creation and documentation of a new or revised departmental procedures and guidelines.
  • Create materials for and represent Clinical Data Management at Business Development related meetings.
  • Assist in the creation of Business Development proposals by supplying data management related information and costs.
  • Represent Advanced Clinical at professional meetings.
  • Participate in the recruitment and selection of Data Management personnel.
  • Perform other duties as requested by management.

Qualifications

A Bachelor's Degree and at least 8 years of experience in data management and/or management approval/recommendation is required. Five years of progressively responsible clinical or data management experience, preferably including project management and staff supervision, with three years of data management experience. The candidate must have strong project management skills, excellent verbal and written communication skills, the ability to serve in a leadership role including effective mentoring skills and the ability to deal effectively with sponsors and internal customers. The candidate must be willing to take on additional projects, work overtime when necessary, and travel on occasion.

Minimum Training Requirements

The list below includes the general training subjects, and not necessarily the exact name of the training course obtained:
  • Applicable Standard Operating Procedures
  • Good Clinical Practices (GCP Regulations' ICH Guidelines; Good Quality Practices)
  • 21 CFR Par 11 and Computer Security (Part 11, Electronic Records; Electron Signature-Scope and Applications; 21 CFR 11 and Industry Guidance's; Computerized Systems Used in Clinical Trials)
  • Good Clinical Data Management Practices
  • HIPPA
  • Drug Development and Approval Process
  • Data Management Overview
  • MedDRA and WHODRUG Overview
  • Sponsor/Study specific trainings, when applicable
  • Applicable system training
At Advanced Group, our commitment to diversity and inclusion in every part of our organization is crucial to fulfilling our mission and demonstrating our REAL values. A diverse staff allows us to effectively draw on different perspectives and enhance our efficiency and effectiveness. Diversity thereby strengthens the legitimacy and relevance of Advanced Group in delivering services to our clients. We seek talented, creative individuals from a variety of backgrounds and cultures to work with us. It is our priority that our workplace be inclusive, welcoming of diverse ideas and appreciative of valuable experience.

Equal Employment Opportunity

It is Advanced Group's practice not to discriminate against any Employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, physical or mental disability, medical condition, military or veteran status, or any other basis protected by applicable federal, state, or local law.

This practice applies to all terms and conditions of employment including, but not limited to, hiring, training, compensation, benefits, promotions, transfers, layoff, Company-sponsored education, social and recreational programs, and treatment on the job. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your Recruiter so that we can meet to discuss the appropriate alternatives available.

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