PRIMARY OBJECTIVE OF THE POSITION:

The primary objective of the Supervisor of Clinical Research Project Administration is to assist the Clinical Operations department to ensure the activities supporting clinical studies are efficient, effective and are conducted in compliance with applicable Regulatory, SOP, Internal Guidance, and Protocol Requirements.

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The ideal candidate will have a Bachelor’s degree and experience in clinical research or the medical field, or a combination of education and experience that indicates the ability to perform the tasks associated with the Clinical Administration Supervisor position. The knowledge/understanding of the principles of clinical research and drug development is desired but not essential. Excellent written and oral communication skills, the ability to manage multiple priorities and attention to detail is critical.

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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 Research Assistant is to provide multi-task administrative support to various clinical personnel for the implementation of clinical studies.

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The candidate should have a scientific background (BS degree or equivalent knowledge and experience). At least 1-2 years of experience in clinical research or a combination of education and experience is preferred. Excellent written and oral communications skills, with the ability to handle multiple tasks and be detailed-oriented is mandatory. Familiarity with multiple computer programs is a plus.

PRIMARY OBJECTIVE OF THE POSITION:

The primary objective of the Clinical Project Manager is to provide project management and leadership to plan, prepare and execute high quality clinical trials. Ensures that all clinical activities related to one or more clinical trials are managed effectively in support of regulatory submissions and subsequent approval of dermatological drugs and devices.

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MAJOR RESPONSIBILITIES AND DUTIES:

The Clinical Project Manager will manage clinical development projects to ensure on time regulatory submission. Effective ongoing communication of the clinical development activities is critical. The Project Manager must have an excellent understanding of the drug/device development process in order to effectively lead the clinical project team. Must be willing to travel up to 20%.

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.