Job#: 3013806

Job Description:

Apex Systems is a world class technology services business that incorporates industry or insights and experience to deliver solutions that fulfill our clients’ digital visions.

Apex has an opportunity for an Senior Manager, Global Clinical Affairs Data. For applicants who are interested in this opportunity, send your updated resume to Mike Konjoian, Account Manager, at [email protected].

Here are the details:

Position: Senior Manager, Global Clinical Affairs Data

Location: Remote

Project Duration: 6 month contract

Rate: Negotiable Based on Experience

JOB DESCRIPTION

The Senior Manager, Global Clinical Affairs Data is responsible for the management of data for all global studies. This includes identifying sources of data, data collection, data processing, data flows, data privacy, data integrity, and data distribution. The Senior Manager, Global Clinical Affairs Data is also responsible for summarizing the data analysis and collaborating in writing a formal report for regulatory agencies.

Responsibilities:

· Identify and manage sources of data, identify efficient data collection pathways, manage data processing, identify and manage data flows, collaborate cross-functionally to ensure data privacy, manage data integrity by implementing quality control checks to ensure accuracy, troubleshoot data issues, and data distribution for all global studies

· Performing User Acceptance Testing of clinical databases

· Liaise with the biostatistician to ensure alignment on data collection and analysis

· Collaborate on study close-out activities and manage the database lock

· Ensure all adverse event documentation is sufficiently detailed to facilitate adjudication

· Collaborate cross-functionally to obtain all study data related to an adverse event

· Manage communication of all adverse event reporting to the Medical Monitor or Data Safety Monitoring Board when applicable

· Manage the finalization of the report shell in collaboration with Medical Affairs

· Summarize the data analysis and collaborate to write a formal report for regulatory agencies

· Manage the distribution of data to clinical sites after the completion of a study

· Manage data retention for each study according to internal processes and regulations

· Define and manage internal data management processes for all global studies

· Develop data management plans for all global studies

· Performs other duties as required.

Education and Experience:

· Bachelor’s degree and/or an equivalent combination of education or experience.

· Minimum of 10 years of relevant experience in the field.

· Must have analytical skills, be detail-oriented, and have good interpersonal skills.

· Knowledge of agency guidelines and requirements.

Skills/Competencies:

· Excellent written and effective verbal communication skills.

· Ability to communicate cross-functionally across the organization.

· PC skills; word processing, spreadsheet, database, Internet search and utilization.

· Flexible and able to work in a fast-paced environment.

· Team player.

· Ability to organize and judge priorities.

· Excellent ability to generate and maintain accurate records

Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing® in Talent Satisfaction in the United States and Great Place to Work® in the United Kingdom and Mexico.

Apex Benefits Overview: Apex offers a range of supplemental benefits, including medical, dental, vision, life, disability, and other insurance plans that offer an optional layer of financial protection. We offer an ESPP (employee stock purchase program) and a 401K program which allows you to contribute typically within 30 days of starting, with a company match after 12 months of tenure. Apex also offers a HSA (Health Savings Account on the HDHP plan), a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program and other discounts. In terms of professional development, Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA. Apex has a dedicated customer service team for our Consultants that can address questions around benefits and other resources, as well as a certified Career Coach. You can access a full list of our benefits, programs, support teams and resources within our ‘Welcome Packet’ as well, which an Apex team member can provide.