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Job Discription
Details:
Inspiration, imagination, and innovation. Here at Aerie Pharmaceuticals, we share this passion for finding new approaches to protecting vision. United by great science, deep clinical insight, and a singular focus on your ophthalmic needs, we see the possibilities ahead and invite you to join us in creating the future of eye care.
Aerie Pharmaceuticals seeks qualified candidates for a full-time position in our Clinical department for the Bedminster, NJ location/in accordance with business needs.
Overall Purpose:
The Clinical Trial Manager (CTM) is responsible for the successful execution of clinical trials from the protocol concept through the clinical study report. The CTM is involved in ensuring completion of study deliverables while typically working on one or more studies with moderate to high complexity (in terms of design, location, phase, etc.). Additionally, the CTM is involved with proactively identifying and resolving clinical project issues and participating in process improvement initiatives as required. They will assist the Director, Clinical Research or designee with the planning, execution, and completion of clinical studies within agreed upon timeframes and within budget, in compliance with the currently approved protocol, ICH and GCP regulations as well as Aerie Standard Operating Procedures (SOP’s).
Duties & Responsibilities:
1. Manage all clinical aspects of assigned study(ies), including: assessment of operational feasibility and recommendation of study execution plan; development and management of comprehensive study timelines and metrics; participation in selection and management/oversight of external vendors and development of vendor specifications; review of vendor reports, budgets, and metrics; provide study-specific training and leadership to clinical research staff (including CRO, CRAs, sites and other contract personnel); prepare and present project debriefings, as required; plan, execute, and lead study-specific meetings (e.g., Aerie and CRO Study Management Meetings, Investigator Meetings, Advisory Committee); participate in site monitoring visits as appropriate for quality oversight.
2. Use operational and therapeutic expertise to optimize trial design and execution: work with the study team to design clinical trial protocols consistent with the clinical development plan and develop an ongoing data review plan to ensure detection of data trends and to ensure study objectives are met; prepare study-related documentation; provide input for the design of the ICF template, CRFs, monitoring conventions, edit checks, etc.
3. Prepare and/or review study-related documents (e.g., Project Management Plan, Clinical Monitoring Plan, TMF Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual, and CRF Completion Guidelines).
4. Prepare/review site level study documents (i.e., site-specific informed consent, study tools/worksheets, investigator contracts, and site payments).
5. Develop and manage study budget and maintain it within financial goals; review and approve clinical invoices against the approved budget.
6. Ensure all clinical trials are executed in compliance with international GCP guidelines/regulations and SOPs: participate in the planning of quality assurance activities and coordinate resolution of audit findings; ensure audit-ready condition of clinical trial documentation including central clinical files; review monitoring reports to ensure quality and resolution of site-related issues; coordinate and assist in the planning of regulatory or ethics committee activities, as appropriate.
7. Coach and provide guidance to clinical staff (e.g. CTAs, CRAs etc.).
8. Interact daily with study assigned Medical Director and members of the cross-functional study team; lead the cross-functional study team as needed; interact frequently with cross-functional internal and external personnel (e.g., Regulatory Affairs, Investigators, CROs, Vendors, etc.).
9. Manage clinical monitoring activities, to include primary or secondary review of monitoring visit reports, to ensure compliance with Good Clinical Practices (GCP) and applicable regulations.
10. Participate in the selection, training, and evaluation of study personnel (contract and internal) to ensure the efficient operation of assigned study(ies).
11. Provide input into the development of study protocols and protocol amendments.
12. Prepare study specific informed consent form (ICF) template. Develop study conduct plans and templates where applicable (e.g. Monitoring Plan, Source Document Verification Plan, CRF Completion Guidelines, etc). Develop patient education materials if needed.
13. Coordinate development of potential investigator list for assigned study(ies).
14. Ensure clinical and non-clinical supplies are available for shipment when required. Responsible to ensure authorized sites have necessary supplies on hand throughout the study.
Qualification Requirements:
Education:
Bachelor’s degree or equivalent combination of education/experience in science or health-related field required
Experience: CTM II – 3- 5 years’ experience as a Manager of Clinical Studies or similar position
CTM III – 5 – 8 years’ experience as a Manager of Clinical Studies or similar position
Knowledge & Abilities:
- Strong clinical study management skills.
- Theoretical and working knowledge of applicable GCP and ICH guidelines as well as basic understanding of the phases of clinical development
- Strong organizational skills and ability to multi-task and manage competing priorities.
- Knowledge of clinical monitoring and site management
- Strong interpersonal skills as well as excellent written and verbal communication skills.
- Positive, team oriented attitude
- Requires computer literacy in several software packages, especially Microsoft Office applications and clinical database software
- Ideal candidate will be a creative problem solver with strong conflict resolution and leadership skills and ability to build and maintain strong relationships in a, sometimes remote based, team environment.
Physical Demands
The physical demands of the position are normally associated with extended amounts of time in front of a computer. While performing the duties of this job, the employee is frequently required to stand, walk, and sit. Travel may be required (up to 25%).
Work Environment
Standard office environment
To perform this job successfully, and individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skills and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Aerie Pharmaceuticals is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status, or other protected category.
Aerie Pharmaceuticals is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status, or any other protected category.
