Advanced Group

Manager, Data Management - International

3+ months agoKyiv, Ukraine

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.

A Manager of Data Management - International (MDMI) is responsible for managing the activities of data management studies and staff in a manner that ensures all time frames and targets are met to the client's satisfaction. A MDMI may oversee all phases of studies for multiple studies across multiple clients and compounds and/or specific roles within the Data Management function.

In addition to their managerial duties, a MDMI may also have data management responsibilities for one or more studies.

Managerial Responsibilities

  • Train, mentor, monitor, and supervise direct reports (including reviewing training files and monitoring time reporting)
  • Coordinate teams and assign resources and projects to ensure all timelines are adequately met
  • Ensure overall quality and quantity of DM activities
  • Conduct performance evaluations for direct reports, including guidance toward reaching organizational and career goals
  • Escalate study status and/or employee issues, as necessary
  • Create training and establish training programs for new processes
  • Identify possible improvements to current processes, determine new processes that are needed, and initiate a plan to improve or develop processes
  • Standard Operating Procedures (SOPs)
    • Be familiar with and follow required SOPs
    • Ensure staff is adequately trained on and following all applicable SOPs
  • Interview job applicants and provide feedback to upper management
  • Other global management responsibilities as requested
Data Management Responsibilities
  • Creation, review and/or approval of study items including, but not limited to:
    • Study-specific plans such as the Data Management Plan
    • Study/Global Conventions
    • Case Report Forms/Electronic Case Report Forms (CRFs/eCRFs) and CRF/eCRF Completion Guidelines
    • Database Specifications/Annotated Case Report Forms
    • Database User Acceptance Testing (UAT) including derivation testing
  • Ensure study tasks are being completed accurately, consistently and within the agreed upon timelines
  • Perform steps pertaining to database freeze/lock/release and coordinate all related activities
  • Act as the main point of contact for client communication
  • Conduct, participate in and/or organize study kick off and lessons learned meetings
  • Create materials for and conduct regularly scheduled meetings with the client
Additional Responsibilities
  • Perform DM Review
  • Perform Quality Control (QC) reviews/checks using the applicable browser tool
Qualifications
  • A Bachelor's degree and at least 5 years of experience in data management with a minimum of 2 years direct report/team management experience.
  • The candidate must possess a full understanding of all aspects of data management and have excellent written, verbal and organizational skills.
  • They must be detail-oriented, a self-motivator, and proficient in the following: query processing, QC Reviews, and Data Management Review.
  • The candidate must be willing to take on additional projects and work overtime when necessary.
Role Competencies
  • Maintains a focus on key priorities and deliverables, staying resilient in the face of pressure.
  • Uses challenges and new situations as an opportunity to learn and improve. Understands own \"facts\" and \"stories\" when in dialogue, and the impact leadership style can have on outcomes.
  • Actively listens and learns from others, demonstrating patience and consideration for others' concerns or frustrations. Asks questions for clarification and ensures message is understood. Takes time to digest what is heard before responding.
  • Visible, approachable, and accessible. Encourages input and participation from colleagues to solve problems and innovate. Provides correct balance of direction and support to staff and colleagues according to each situation. Understands differences, anticipates areas of conflict and takes action.
  • Evaluates and measures current processes. Works with a view of the future, prioritizing work in line with organizational objectives. Improves processes to maximize use of resources.
  • Seeks opportunities to develop professional skills and knowledge and encourages team to do so. Supports and directs where appropriate, including recognizing achievements and providing constructive feedback and guidance. Cross-train others to broaden experience and develop potential.
  • Translates major new directives into individual performance expectations. Explains and convinces others of the need for adaptation and change of policies, structures, and methods.
  • Is comfortable facing issues with team members quickly and directly. Is willing to choose an approach that has not been tried before, or a leadership style that feels less comfortable if the situation demands it. Takes personal risks regularly and is not afraid to express bold opinions if the intention and motive is good.
  • Consistently reflects the REAL values and inspires team to live and work by these values.
This job description is a summary. It is not intended to be comprehensive in detail. Individuals with this job title will be expected to perform according to their individual goals and evaluations in addition to this job description and all applicable standards (SOPs, manuals, code of conduct, laws, regulations, etc.).

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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Job ID: A_RPO-13335