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Medical Operations Specialist

Employer
Syneos Health
Location
Krakow-22-Zielinskiego, POL
Salary
Competitive
Start date
27 Sep 2021
Closing date
6 Oct 2021

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Discipline
Medical Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

Here at Syneos Health we are currently recruiting for a Medical Operations Specialist

Why Syneos Health
• #SyneosHealthLife means we're committed to our Total Self culture - where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person's unique contributions make a difference.
• We believe our success is a direct result of the people who are driving it - you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That's why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong.

Job details:
Performs data entry, creation and maintenance of files, spreadsheets, proposals, and reports. Assists with the
reviews and analyses of project specific data and management of study-related committees.

Responsibilities for this role are as follows:

1. Performs data entry of medical monitor contact reports (MMCRs) into ProjecTrend and/or IMPACT, while
tracking and organizing MMCR data.
2. Assists Medical Affairs Scientists with review of medical data listings, Case Report Form (CRF) line and lab
listings, and medical coding; highlights areas for medical review
3. Supports study-related committees by attending meetings, preparing meeting minutes, and maintaining all
committee-related documents. May serve as a committee manager.
4. Uploads and manages documents collected for pre-enrollment review and endpoint adjudication into
TrialEASTM.
5. Supports the Medical Affairs and Medical Operations departments and staff with the following duties:
a. Performs file creation, retention, and maintenance (paper and electronic);
b. Maintains Medical Monitor and Medical Operations study assignment roster, including tracking the
assignment of back-up staff where appropriate;
c. Maintains request for proposals (RFPs) spreadsheet including tracking awarded and lost projects pertaining
to Medical Affairs;
d. Initiats and follows up with study sites as necessary;
e. Maintains the SharePoint web sites for Medical Affairs and Medical Operations by granting user access,
creating new document libraries, and updating "out of office" calendar for department members.

6. Ensures compliance with the Code of Federal Regulations (CFR), HIPAA, state regulations, International
Committee on Harmonization (ICH), and GCP guidelines, and sponsor Standard Operating Procedures (SOPs),
and Work Instructions (WIs), where appropriate.

OTHER RESPONSIBILITIES:
Performs other work related duties as assigned. Minimal travel may be required (up to 25%).The ideal candidate will need the following experience / skills to be considered:

BA/BS in the biological sciences or related discipline in the natural sciences/health care field, nursing degree, or
equivalent combination of education and experience. Solid office/administrative experience. Nominal clinical
research or medical clinic/hospital experience preferred. Good knowledge of ongoing protocol and disease related
terminology and the drug development process, including database and medical terminology. Advanced proficiency
in Microsoft Office Suite (Word, Excel, and PowerPoint), email, and voicemail. Strong customer service skills with
effective written and verbal communication appropriate to a professional medical setting. Strong organizational,
presentation, documentation, and interpersonal skills, as well as a team oriented approach. Excellent verbal,
written, and communication skills. Ability to multitask to meet tight deadlines in a dynamic environment while
providing attention to detail and high quality work.

Disclaimer:
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole
discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience,
skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the
Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the
qualifications described above. Further, nothing contained herein should be construed to create an employment
contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained
herein is intended to fully comply with all obligations imposed by the legislation of each country in which it
operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment
of its employees.

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