Clinical data associate job description

Kelly Science and Clinical FSP is currently seeking a Clinical Data Associate for a long-term engagement with one of our Global Pharmaceutical clients. This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and is offering full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vision, 401K and a variety of other benefits to choose from. You may also be eligible for paid time off, including holiday, vacation, and sick/personal time.
**Clinical Data Associate**

**OVERALL RESPONSIBILITIES:**

The Clinical Data Associate will be responsible for all aspects of clinical data management associated with data cleaning and quality review processes for assigned projects. S/he ensures clinical trial data collected meet the highest standards of data integrity, while meeting timelines and budgets.

**POSITION DUTIES & RESPONSIBILITIES:**

Reporting to the Director this individual will;

+ Support CRF design, review and validation of clinical database;

+ Ability to perform all aspects of user acceptance testing associated with clinical study databases including but not limited to review of test scripts, facilitation of test script approvals and execution of test scenarios defined within the test scripts with minimal supervision;

+ Have the ability to support a number of complex trials with minimal supervision;

+ Be responsible for creation of data management plans and other data management documentation;

+ Monitor progress and conduct of their respective projects, including all data cleaning and QC activities to ensure all remain on target to project timelines;

+ Be responsible for coordinating, facilitating and participating in all data management activities from initiation of protocol through database lock with minimal oversight, partnering as appropriate with Clinical Operations, Franchise and other BSDM functions for their respective projects;

+ Be responsible for participating in ongoing data review throughout the conduct of the study, oversee the correction of errors and discrepancies management for the life of a project;

+ Proactively identify and address issues that may impact the quality of the data, deliverables or timelines;

+ Be responsible for handling and overseeing of non-CRF data, including lab data and image handling;

+ Be responsible for coordinating with Medical Affairs organization to facilitate data coding and safety reviews as needed;

+ Manage process improvement, data standards and efficiency gaining initiatives within data management working with data management leadership as needed;

+ Be responsible for ensuring all clinical data management documentation is stored and archived in a timely and compliant manner;

+ Know and follow all laws and policies that apply to the job, and maintain the highest levels of professionalism, ethics and compliance at all times;

+ Diligently participate in compliance program-related activities

+ Performs other related duties as required.

**Functional and Technical Competencies** **:**

+ Therapeutic area knowledge in at least one of orthopedics, gynecology, cardiovascular, or general surgery.

+ Proficient in computer technology used in an office environment (Microsoft Word, Excel, etc).

+ Strong verbal and written communication skills.

+ Knowledge of GCP and regulatory requirements regarding clinical data management documentation and software.

+ Experience with Electronic Data Capture (EDC), Medidata RAVE preferred. Knowledge of medical terminology and use of coding dictionaries (MedDRA, WHO Drug).

**EDUCATION & EXPERIENCE REQUIREMENTS:**

+ A Bachelor's degree (or equivalent) in the biological sciences, Computer Science or related discipline, with 3 years of clinical data management experience in Medical Device or Pharmaceuticals. Experience of supporting trials with minimal supervision.

**Top 3 Most Critical "Must Have" Job Requirements are** : Tech expertise, Communication skills, Understanding of industry trends and hands on DM experience.

**Must Haves:** SAS Programming understanding, electrophysiology

**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.

**Why Kelly** ** ** **Science & Clinical?**

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals-it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

**About Kelly** ** **

At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's Human Resource Knowledge Center.
Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.

About the Job


The Clinical Data Operations Associate in Data Management performs a range of activities in support of functional processes and contributes to the continual improvement of department processes, knowledge management and training initiatives. This position performs operational and tactical support for BioPharma, FMI and Academic Collaborator clinical trials. The Clinical Data Operations Associate ensures accurate sample tracking, receipt of accurate information about samples from partners, Query management and resolution, data entry for complex studies, accurate and timely data reporting, and coordination of sample returns. The role works closely with internal and external teams within FMI.


Key Responsibilities

• Provide ongoing study operational support.

• Setup folder structure for all new studies in study repository/Trial Master File (TMF).

• Monitor archiving of study documentation in study repository/TMF as study is ongoing and at closure.

• Track sample processing and deliver study specific sample status reports (SST) to Clinical Program Leads identifying samples that have passed, are on hold, and/or have failed.

• Monitor query process and query partners/collaborators to obtain missing information.

• Complete Study Intake information in CRM/Clinical Trial Management System.

• Manage sample return and destruction process for all Partners/Collaborators.

• Submit final report for Pathology approval.

• Upload, enter, and maintain study sample data in FMI's internal data management and reporting systems.

• Handle query management and resolution.

• Perform quality control and ensure accuracy of all data provided to our Academic and Pharmaceutical partners.

• Ensure quality standards for data reporting are met, including compliance with HIPAA, GDP, and GCP.

• Proactively identify and raise issues related to data integrity and process improvements; provide recommendations for resolutions as needed.

• Coordinate and communicate all relevant study activities to ensure timely delivery of partner milestones.

• Collaborate cross-functionally with sub-teams including Bioinformatics, Data Management, Clinical Operations, Lab Operations and Technology for:
  • Releasing reports and holding reports;
  • Report template and IXRS (interactive response system) transfers;
  • Daily study-specific reporting workflows to ensure deliverables meet TAT (Turn Around Time);
  • Partner Relationship Management;
  • Internal Tech Solutions with WLM (Work List Manager), BI (Business Intelligence), PRA (Pharma Reporting Application, Partner Portal and CRM (Customer Relationship Management).

• Other duties as assigned.

Qualifications



Basic Qualifications

• Bachelor's Degree in a health or science field

Preferred Qualifications

• 1+ year(s) of professional work experience in the science or health industry

• Familiarity with oncology, clinical research, molecular biology, genetics and/or bioinformatics

• Successful history of performing tasks under deadline pressure

• Demonstrated strong attention to detail

• Demonstrated ability to work with a cross-functional team

• Ability to perform assignments with minimal supervision and in a timely manner

• Excellent verbal and written communication skills

• Strong organizational, administrative, and analytical skills

• Strong prioritization skills

• Understanding of HIPAA and the importance of patient data privacy

• Commitment to values held at FMI: Patients, Innovation, Collaboration, and Passion

#LI-HybridFoundation Medicine, Inc. (FMI) began with an idea - to simplify the complex nature of cancer genomics, bringing cutting-edge science and technology to everyday cancer care. Our approach generates insights that help doctors match patients to more treatment options and helps accelerate the development of new therapies. Foundation Medicine is the culmination of talented people coming together to realize an important vision, and the work we do every day impacts real lives.

Foundation Medicine is proud to be an Equal Opportunity and Affirmative Action employer and considers all qualified applicants for employment without regard to race, color, religion, sex, gender, sexual orientation, gender identity, ancestry, age, or national origin. Further, qualified applicants will not be discriminated against on the basis of disability or protected veteran status. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements. See also FMI's EEO Statement and EEO is the Law and Supplement . If you have a disability or special need that requires accommodation, please let us know by completing this form . (EOE/AAP Employer)