Axios Clinicals
CAREERS
Clinical Data Manager
OVERVIEW
We are currently searching for a skilled professional to join a well-known client’s team in Lincolnshire, Illinois as a Clinical Data Manager. This remote role will oversee the clinical data tasks from study start-up through database lock for company clinical projects. Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.
EXPERIENCE
- Minimum of 7 years of clinical research background experience in data management required
- Detailed knowledge of clinical database applications such as EDC and CTMS
- Knowledge of global standards related to data management activities (CRF design, database, design, and standards)
- Proficient computer skills including MS office products required, Laboratory and/or LIS computer skills desired
- Good organizational and communication skills
- Excellent project and time management skills
- Travel required – up to 20%
EDUCATION
- Minimum of Bachelor’s Degree in science related field required
To be a best-fit your strengths must include:
- Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.
- Organized. You’re an efficient time-manager and can handle the pressure of meeting multiple strict deadlines.
- Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure.
- Problem-Solvers. As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
- Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
- Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.
RESPONSIBILITIES
- Define and direct the data management workflow and ensure all necessary data quality control measures/documentation are in place
- Establish Case Report Form (electronic and/or paper) according to the clinical protocol
- Develop database clinical data specifications and ensure appropriate validation of the databases
- Create Data Transfer Agreement(s) between external data vendors and/or external labs
- Perform training on study trial for EDC and create user guides
- Ensure quality check of clinical data
- Manage database lock, close-out audit, and archive activities
- Generate, review, and ensure compliance with standard operating procedures that govern clinical data management
- Participate in the review of clinical research documents
- Create data listings, summary table validation, data specifications, and/or process data transfers to prepare for statistical review and/or data management audits
- Ensure data system compliance with the established guidelines of national/international regulatory authorities
Regarding your application
Please know that every completed application is carefully reviewed by the our recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.
It is our practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity/expression, sexual orientation/sexual preference, pregnancy/maternity, genetic information, marital status, physical/mental disability, medical condition, military/veteran status, or any other basis protected by applicable federal, state, or local law. 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 discuss the appropriate alternatives available.
Please fill out the form below as it relates to the above job opening. A member of our team shall reach out to you thereafter. In the event you do not meet the criteria for the position, we shall notify you about relevant positions, and keep you in mind whenever we have the right opportunity for your skillset.
If you need urgent support, simply call our 24 hour emergency hotline.
Your personal case manager will ensure that you receive the best possible support.
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