Clinical Data Manager II

Position Summary:

The Clinical Data Manager II manages all aspects of the clinical trial data management process from study start up to post database lock for assigned projects under some supervision. Standard Operating Procedures / Work Instructions (SOPs/WIs); regulatory directives; study specific plans and guidelines will be followed. This position will also oversee and/or perform database development and testing.

Essential functions of the job include but are not limited to:

Primary Data Management (DM) contact (Lead DM role) and/or contributor for assigned clinical project(s) / program(s), ensuring that there is back-up, continuity, responsiveness, and that tasks are performed in a timely manner. May support another Lead DM as a backup and/or team member.

May perform data entry for paper-CRF studies, as needed

May perform quality control of data entry

Provide input into timelines. Ensure that clinical data management deadlines are met with quality. May assess resource needs for assigned projects, as needed.

Develop CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholders

May assist in building clinical databases

Conduct database build UAT and maintain quality controlled database build documentation. Oversee overall quality of the clinical database.

Specify requirements for all edit check types e.g. electronic, manual data review, edit checks, etc.

Responsible for creating, revising, appropriate versioning and maintaining data management documentation. Oversee completeness of data management documentation for the Trial Master File

Train clinical research personnel on the study specific CRF, EDC, and other project related items as needed

Review and query clinical trial data according to the Data Management Plan

Perform line listing data review based on the guidance provided by the sponsor and/or Lead DM

Run patient and study level status and metric reporting

Perform medical coding of medical terms relative to each other in order to ensure medical logic and consistency

Coordinate SAE/AE reconciliation

Liaises with third-party vendors such as external data and EDC vendors in a project manager capacity in support of timelines and data-related deliverables

May assist with SAS programming and quality control of SAS programs used in the Data Management department

Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders

May assist in reviewing and providing feedback on protocols, Statistical Analysis Plans (SAP) and Clinical Study Reports (CSRs), if required by the project

Participate in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management and database management activities

May attend strategy meetings, bid defense prep meetings, bid defenses, capability presentations, potential client engagement meetings

May review Request for Proposals (RFP), proposals, provide project estimates

Trains and ensures that all data management project team members have been sufficiently trained

Communicate with study sponsors, vendors and project teams as needed regarding data, database or other relevant project issues

May present software demonstrations/trainings, department/company training sessions, present at project meetings

May require some travel

Perform other duties as assigned

Qualifications:Minimum Required:

Bachelors and/or a combination of related experience

Other Required:

5+ years’ Clinical Data Management experience or demonstrated aptitude in the key skills for the role

Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook

Able to handle a variety of clinical research tasks

Excellent organizational and communication skills Must be able to read, write, speak fluently and comprehend the English language to enable communication across Precision for Medicine and with clients

Experience in utilizing a clinical database management system

Broad knowledge of drug, device and/or biologic development and effective data management practices

Ability to undertake occasional travel

Preferred:

Understanding of dictionary medical coding (MedDRA and WHODrug)

Understanding of CDISC standards (CDASH, SDTM, ADaM, etc.…)

Oncology therapeutic experience

Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits.Reasonable estimate of the current range$100,700—$166,100 USD

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Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.

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