CLINICAL:

1. Primary point of contact for investigator payments
2. Create/maintain standard rate list.
3. Work with Research Clinic Manager to track/manage/negotiate budgets.
4. Work with Legal to track and manage the contract process from negotiation to execution.
5. Set up protocol budget in Allegro in accordance with contract specifications.
6. Assist with clinical revenue reporting/forecasting.
7. Work with Project Managers to review investigator budgets.
8. Record negotiated budgets in finance workbooks.
9. Enter budgets in CTMS and process monthly investigator payment requests.
10. Review clinical trial vendor budgets against work orders.

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BUSINESS DEVELOPMENT:

1. Work with the Director, Business Development to create WO/CO budgets.
2. Maintain standard rate sheet.
3. Initial drafting of all work orders for awarded projects.
4. Initial drafting of all change orders.

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Education/Qualifications

• A Bachelor’s degree in accounting/finance.
• Proficient in MS Excel, MS Word and Email applications.    
• Experience with CTMS platforms preferred.
• Comparable work experience in clinical research, preferably CRO finance related, 3 years minimum required.
• Clinical research budget experience preferred.

The primary objective of the Clinical Data Associate is to provide support to the Data Management (DM)department. This will include administrative tasks, data entry of clinical trial data into study databases, participation in database validation, providing study status metrics and reports, and data review under the supervision of the lead Clinical Data Manager (CDM) to ensure the completeness, accuracy, and consistency of the data collected during clinical trials.

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The candidate should have a scientific background (BS degree or equivalent knowledge and experience) with 0-2 years of relevant industry experience. The individual must be extremely detail-oriented while still maintaining work efficiency, be able to prioritize activities and multi-task across multiple projects, and enjoy problem solving and learning new systems and processes. Excellent written and oral communications skills are also required. Previous experience using electronic data capture (EDC) platforms (DSG’s eCaselink is preferred) and MS Excel is desired.

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The primary objective of the Sr. Clinical Data Manager is to coordinate and complete in-house data management activities to ensure the accuracy and consistency of clinical databases for subsequent analysis and reporting.

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The candidate will have a scientific background (BS degree or higher) with at least 5 years of clinical data management experience in the pharmaceutical/biotechnology industry. The individual must be highly detail-oriented while still maintaining work efficiency, be able to prioritize activities and multi-task across variousprojects that will be at different study stages. MedDRA and WHO Drug coding proficiency is preferred. Previous experience with reviewing data and database validation for EDC (DSG’s eCaselink is preferred) is required. Knowledge of CDISC/SDTM standards is also highly desired.