Position: Clinical Data Manager
Company: promdex
Category: Project Manager
Experience required: 2y
English level: upper

Clinical Data Manager (CDM) Entry Level is responsible for traditional clinical data management operations and activities such as managing and collecting data from clinical trials and research studies, facilitating database audits, coding, SAE reconciliation, system and module testing, data cleaning, and locking and unlocking of clinical databases. All these operations and activities will be performed under the guidance or monitoring of an experienced CDM or Lead CDM.

QUALIFICATIONS REQUIRED:
Ability to communicate effectively in the English language in person, by phone, and in writing;
Strong attention to detail and accuracy is a must;
Excellent organizational skills;
Demonstrated ability to manage multiple projects;
Ability to work collaboratively, effectively, and productively in diverse organization structures;
Ability to work independently, take initiative, and complete tasks to deadlines: Delivering Excellence, Serving Customers, Accountability and Ownership, Global and Cross-Functional Communication;
Ability to work in a team-oriented, collaborative environment;
Ability to work positively within a continually changing environment;
Ability to effectively prioritize and execute tasks in a high-pressure environment;
Advanced computer skills and practical knowledge of MS Office and potentially project management software.


EDUCATION AND EXPERIENCE REQUIRED:
A Bachelor’s degree or equivalent combination of Education/Training/Experience is required. A degree in a scientific, medical, or technological discipline is preferred;
Clinical trial or clinical data management experience or similar industry experience/training is preferred;
Prior trial responsibility for the entire data management life-cycle is desirable.


TRAINING:
Complete Training Requirements per current Training Requirements List;
The supervisor may assign additional skills training, one-on-one, see-one / do one, or other Training as necessary to achieve qualifications and improve job performance.  
REQUIRED TECHNICAL BACKGROUND
organizational skills
communication skills
management skills
Problem solving
MS Word
Excel
PowerPoint
project management software
ADDITIONAL SKILLS
PhD degree in a Scientific or related field will be a big plus.


English - Advanced (I feel comfortable to be interviewed)

WORK EXPERIENCE
2+ years

JOB RESPONSIBILITIES
The Entry Level CDM will have the opportunity to handles project management documentation, clinical data management activities, and system implementations for companies Panther eClinical with assistance and guidance from an experienced CDM or Lead CDM. Entry Level CDM will be involved in writing design specifications for the system (forms, reports, etc.), facilitating testing of system implementations, translating the client’s Clinical Data Management requirements and expectations into data management plans, and implementing the clinical data management plans so that the client’s expectations are met.
The Entry Level CDM will be trained for Good Clinical Data Management services, including its documentation; be involved in a start-up or wrap-up of in-house and client-specific data management projects.

 

ESSENTIAL FUNCTIONS
Support Internal Clinical Data Management Initiatives;
Complete Traditional and Assigned Data Management Operations/Activities;
Contribute to Project Success by Conducting Duties per CDM/LCDM Request;
Design Case Report Forms (CRFs);
Assist in the Development and Maintenance of Systems Used to Support Project Infrastructure;
Work with Clinical Data Specialists (CDSs) to Execute Data Management Plans;
Work with Clients/Sponsors as Necessary to Deliver Contracted Clinical Data Management Services and Clinical Data with High Quality and Integrity;
Code Data per Selected Coding Dictionaries;
Clean Data;
Develop / Execute Testing Strategies;
Assist with Data Transfers, Loading, and Integration;
Complete All Required Documentation per Project Requirements;
Perform Use Acceptance Testing (UAT) on New Software;
Classify Clinical Events per Agreed-upon Strategies/Plans Classification.
WORKING CONDITIONS
🦄 Full-time/remote (home-based)/long-term position. 40 hours per week, 8 hours per day, Monday-Friday. The working schedule is flexible, mostly it's close to the EST time zone. Home-based working environment. Cross-functional interactions.



🧘 26 paid days of vacation per year, i.e. PTO - paid time off. 1.5 PTO is accrued for each full-time month of work : 18 paid days per year. Additionally, each associate is allowed to use 'Holidays' - paid time off to be spent during state holidays. 2 Holidays are accrued each quoter and could be used at any time - 8 per year. Please follow the link to check the principles of our work: http://tiny.cc/awwcor

ABOUT COMPANY
The Client represents an innovative clinical solutions company that provides high-quality technology platforms and related clinical services to pharmaceutical, biotechnology, and medical device companies. From its headquarters in Princeton, NJ, and offices in Asia and Europe, the Company has delivered innovative solutions since 2009 resulting in unparalleled advantages for clinical development related to data quality, time of completion, and cost-efficiency.


TEAM SIZE AND TEAM STRUCTURE
The current SAS team consists of 9 people managed by the Team lead (Ukraine) and President (the US). The team is working remotely and based in Kyiv. The company has different departments: Statistic and Business Intelligence, BA, QA, Engineering, Cloud & IT, etc. Our remote team is about 80 people now.


STAGES OF THE HIRING PROCESS
If you are interested, the process is as follows:
1) You register on our website and leave your application with your full CV in pdf or doc format;
2) We arrange up to 30 min video call to discuss the key points;
3) English Test (up to 15 min call);
4) Technical interview;
5) Offer.