Clinical Data Manager

FLSA Classification: Exempt/Salary 

Schedule: Monday – Friday; 8:00 am – 5:00 pm; possible evening and weekend work 

Department: Clinical Sciences 

Reports to: Associate Director Clinical Sciences 

Supervisory responsibilities: No 

Location: Fully Remote 

Position Summary/objective: 

Ensuring GCP compliance in all data management related topics as well as integrity and 

 quality of all collected and stored data of a clinical trial. 

Essential functions: 

Main responsibilities of this position will include but are not limited to the following tasks:  

• Planning, conduct and closure of clinical trial data management activities within timelines, budget and with high quality 

• Providing functional area input into GCP/GCLP vendor selection and support with vendor qualification from Clinical Data Management point of view following the effective SOPs 

• Performing / overseeing of following clinical data management activities 

• Clinical trial set up phase: data management plan, database (eCRF design specification, edit check specification, data review plan, eCRF completion guidelines, IRT specification, Coding Plan, SAE reconciliation Plan, data transfer specifications, database programming, UAT plans, UAT performance, database GO Live, etc. 

• Clinical trial maintenance phase: data reconciliation, data listings, data review, query management, data cleaning, data transfer, management of laboratory normal ranges, site & user access management, etc. 

• Clinical trial close out phase: Final reconciliation, query closing, patient profiles, database lock. QC (Quality Control) of all filed documents.  

• Performing or overseeing of development, implementation and change management of clinical data management systems (i.e., eCRF & RTSM (Randomization and Trial Supply Management), Imaging, SAS, Review, etc.) 

• Ensuring Clinical Data Management related training of clinical trial team and external vendors  

• Ensure CDISC standards are followed (SDTM/CDASH/ADAM)  

• Participate in the definition and implementation of eCRF / IRT standards  

• Reviewing and input of clinical trial documents (i.e., clinical trial protocols, statistical analysis plan, safety management plan, DSMB (Data and Safety Monitoring Board) Charter, Deviation Plan, Medical Monitoring plan, etc.)  

• Managing and overseeing centralized monitoring 

• Developing and maintaining SOPs, guidance documents, Templates, standards, training material for clinical data management tasks 

• Data management related System Validation 

• Archiving of clinical trial data management related documents as per TMF Ref Model 

Secondary functions: 

• Support in Trial Budget oversight for Data Management Budget, support in Vendor management, DB- Programing, CDISC Compliant 

Competencies: 

• Identifies and fulfills tasks under own responsibility. 

• Can manage project teams and work across departments  

• Does not require any or very limited supervision.  

• Can give presentations and write relevant official documents without supervision (e.g., CRFs (Case Report Forms) and Data Management Plans) 

• Full reflection on complex process structures and connections  

• Comprehensive understanding of priorities within own and broader scope with limited interaction of the supervisor 

• Proactively driving company standards, global harmonization and innovation in own scope 

• Proactively driving high quality and efficiency to meet timelines and milestones 

• Open minded for rapidly changing requirement 

• Outside the box thinking and a high degree of flexibility in an environment which is marked by a constant striving for excellence 
   

Work environment: 

This position is remote and should be performed in an office setting that simulates the work office environment. This office must be set up in a way that allows for privacy and quiet during work hours, as well as a comfortable chair and desk. This position uses phone, computer, office equipment and supplies on a regular basis. Noise levels should be at a level which would allow for proper communication with other members virtually.    

Physical demands: 

• Communicating Verbally – expressing or exchanging ideas by means of the spoken word to impart oral information to others to convey detailed spoken instructions or other workers accurately, loudly or quickly. 

• Hearing – the ability to hear, understand, and distinguish speech and/or other sounds one-on-one, group or conference, telephone, and other sounds. 

• Keyboarding – entering data or text into a computer or other machine by means of a keyboard. Devices include a traditional keyboard, 10 key-pad, touch screens and others.  

• Near Visual Acuity – clarity of vision at approximately 20 inches or less (working with small objects, reading small print, including the use of computers).  

• Sitting – remaining in a sitting position for at least 50% of the time. 

Travel required:   

As required for Team Events/Meetings, Trial/Investigator Meetings, Trainings 

Required education and experience: 

• Master's degree in Life Sciences (e.g., biology, chemistry, pharmaceuticals) or Computer Sciences or comparable experience  

• At least 5 years of experience in data management in the pharmaceutical/biotechnology industry  

• Experience with EDC and IRT (Interactive Response Technology) systems 

• Experience in data management project management 

• Database programming expertise  

• Comprehensive knowledge of ICH-GCP, FDA and EMA regulations  

• Advanced leadership skills and strong team player  

• Proficient organization skills 

• Advanced presentation skills 

• Strong ability to identify, deeply analyze and communicate problems 

• Proficient ability to develop and independently implement solutions 

• High ability to anticipate future risks 

Preferred education and experience: 

• Knowledge of medical terminology, Coding, Coding dictionaries, SAE reconciliation 

• Experience with specific EDC and IRT systems: 

• RAVE EDC 

• RAVE RTSM 

• others 

• Expertise in SAS programming / R programming 

• CDISC (CDASH, SDTM) expertise 

• Experience in oncological studies 

Additional eligibility requirements: 

Proficient verbal and written communication skills in English. 

Work authorization/security clearance requirements: 

Legal eligibility to work in the United States is required. Immatics participates in E-Verify and all new employees will be subject to the Department of Homeland Security requirements for employment 

Affirmative Action/EEO statement: 

Immatics is an equal opportunity employer. All employment decisions including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. We do not discriminate on the basis of race, color, religion, national origin, ethnicity, marital status, age, physical or mental disability, medical​​​ conditions, pregnancy, genetic information, gender, sexual orientation, gender identity or ​expression, veteran status, or any other status protected under federal, state, or local law.” 

Other duties:  

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. This job description may not cover all duties that take place on a daily basis and may be changed as business needs change. Employee will be responsible for adapting and learning the duties as described above or as the new ones are introduced.