AIM OF THE POSITION

The Clinical Data Manager is a highly motivated and hands on person, who is responsible for the coordination and management of planning, reviewing, and cleaning clinical trials data and/or clinical development data.

POSITION WITHIN THE ORGANIZATION

Reports to Director, Clinical Science

2. This position may interface with all departments within the company as well as outside vendors and regulatory agencies.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Ensure all data management activities (including study data) is collected, processed, and stored in accordance with GCP, regulatory requirements, and study-specific protocols

Design and modify eCRFs and EDC edit checks

Responsible for building, review and validation of clinical database

Serve as domain expert in providing guidance to study teams on data management issues, including database design, CRF development, EDC, and data cleaning

Develop and propose process or system improvements for global implementation

Generate standardized and ad-hoc metrics, reports to facilitate ongoing data review for internal/external team meetings

Manage and execute data cleaning and query resolution activities to ensure that data is of high quality and is accurate

Review team member activities and deliverables to ensure plans and

processes are followed

Partner with cross-functional team leads and stakeholders to generate datasets for analysis and reporting

Create and maintain project DM documentations

Work with Medical/Clinical team leads and CRAs to review data and identify inconsistencies

Oversee System Development and modifications:

a. Review the CRF design, annotated CRFs, edit check specification and DM listings

b. Assist clinical team to facilitate clinical team review of system and/or specifications (Online Screen Review, Edit Check Review, Data Review Plan review, etc.).

c. Ensure all non-DM activities related to database development are completed in a timely manner

d. Ensure all database modifications are communicated with team and implemented effectively

e. Review database developments to ensure standard implementations across studies

Oversee Database lock activities:

a. Facilitate final team review of data and review documentation for database locks

b. Ensure comments from internal/sponsor for discussion are documented

c. Ensure all non-DM activities related to database lock are completed in a timely manner

d. Create and Maintain documentation for templates (DMP, CRF Completion guidelines, Trial Design Document, Edit specifications, Reconciliation guidelines, Report specifications)

Train others on specific departmental processes (Trial design document creation, Edit Check creation, change control process, database lock, etc.)

The above listing represents the general duties considered essential functions of the job and is not to be considered a detailed description of all the work requirements that may be inherent in the position.

EDUCATION

o Bachelor’s degree, preferred in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy) required.

o Successful completion of ICH/GCP course

o Research Professional Certification- (CCRA, ACRP-CP) or exam eligibility desired

EXPERIENCE

BS degree required, preferred in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy) required.

2+ years related clinical trials data management experience as a clinical trial professional.

Strong knowledge of clinical operations and the regulatory process.

Knowledge of molecular diagnostics

PREFERRED QUALIFICATIONS

Knowledge of programming languages (i.e. SQL) and basic data analysis.

Knowledge of oncology

KNOWLEDGE, SKILLS AND ABILITIES

Specific Knowledge Required:

Examples:

o Demonstrated ability to work in cross-functional, multicultural and international teams.

o Excellent communication, organization and tracking skills; project management experience desirable.

o Working knowledge of scientific principles and medical terminology.

o Oncology knowledge.

o A thorough understanding of clinical research methodology including study design, concept development, protocol writing and preparation and knowledge of GCP and local regulatory requirements.

o Solid teamwork, organizational, interpersonal, and problem solving skills; exercises good judgment with respect to Agendia’s confidential information and strategies.

o Demonstrated ability to accurately and effectively evaluate medical/scientific literature and apply this knowledge to study design. Basic understanding of medical aspects of interventional therapies along with willingness to develop in-depth expertise.

o Ability to travel both for day trip and up to several nights at a time for up to 20%

BEHAVORIAL COMPETENCIES

Examples:

o Ability to multi-task

o Result – and customer orientation

o Self-organization

o Quality oriented and results focused

o Initiative

o Flexibility

o Can do-attitude

PRIVACY NOTICE: To review the California privacy notice, click here: https://agendia.com/privacy-policy/

WORKING ENVIORNMENT

Establishes ADA (Americans with Disabilities Act) requirements

ENVIRONMENT/SAFETY/WORK CONDITIONS

Working conditions (inside or outside the office).

Examples:

o Regularly walks, stands, and sits

o Regularly works on a computer for approximately 6-8 hours a day

o Regularly works with pipettes (or other equipment and tools)

o Frequently lifts, pushes/pull, and carries up to 20 pounds

o Exposed to extreme cold for typically 2 hours per month when assisting with removing samples from freezers or loading inventory

o Exposed to hazardous materials (dry ice) on a monthly basis

o Must follow lab safety practices when working in freezer or with hazardous materials including use of personal protective equipment such as: gloves, lab coats, and safety glasses

o Must be able to read and understand scientific and complex directions

TRAVEL

o Ability to drive/fly routinely including overnight visits – 20%

OTHER DUTIES

Other duties as required (this is the last responsibility for every job description).

Job Type: Full-time

Pay: $105,000.00 - $130,000.00 per year

Benefits:

401(k)
401(k) matching
Dental insurance
Employee assistance program
Flexible spending account
Health insurance
Life insurance
Paid time off
Referral program
Tuition reimbursement
Vision insurance

Schedule:

8 hour shift
Monday to Friday

Work Location: Hybrid remote in Irvine, CA 92618

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