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 located in our Bedminster, NJ office.
The Clinical Trial Manager (CTM) is responsible for the successful execution of clinical trials from the protocol concept through the clinical study report, ensures completion of study deliverables, typically works on studies with moderate to high complexity (in terms of design, location, phase, etc.), and proactively identifies and resolves clinical project issues and participates in process improvement initiatives as required. Assists the Clinical Research Director or designee with the planning, execution and completion of clinical studies within agreed upon timeframes and budget and in compliance with the currently approved protocol, ICH and GCP regulations as well as Aerie Standard Operating Procedures (SOP’s). May be responsible for more than one study.
Duties & Responsibilities:
1. Manages all clinical aspects of study, including: assesses operational feasibility and recommends study execution plan; develops and manages comprehensive study timelines and metrics; participates in selection and management/oversight of external vendors and develops vendor specifications; reviews vendor reports, budgets, and metrics; provides study-specific training and leadership to clinical research staff, including CRO, CRAs, sites and other contract personnel; prepares and presents project debriefings, as required; plans, executes, and leads study-specific meetings (e.g., Study Management Meetings, investigator meetings, Advisory Committee); participates in site monitoring visits as appropriate.
2. Uses operational and therapeutic expertise to optimize trial design and execution: works 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; prepares study-related documentation; provides input for the design of the ICF template, CRFs, monitoring conventions, edit checks, etc.
3. Prepares and/or reviews study-related documents (e.g., Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual, and CRF Completion Guidelines).
4. Prepares/reviews site study documents (i.e., site-specific informed consent, study tools/worksheets, investigator contracts, and site payments).
5. Develops and manages study budget and maintains it within financial goals; reviews and approves clinical invoices against approved budget.
6. Ensures all clinical trials are executed in compliance with international GCP guidelines/regulations and SOPs: participates in the planning of quality assurance activities and coordinates resolution of audit findings; ensures audit-ready condition of clinical trial documentation including central clinical files; reviews monitoring reports to ensure quality and resolution of site-related issues; coordinates and assists in the planning of regulatory or ethics committee activities, as appropriate.
7. Coaches and provides guidance to clinical staff.
8. Daily interaction with study Medical Director and members of the cross-functional study team; lead the Cross-Functional Study Team as needed; frequent cross-functional interactions with internal and external personnel (e.g., Regulatory Affairs, investigators, CROs, vendors, etc.).
9. Knowledge of GCP, ICH guidelines and regulatory requirements for clinical trial management; strong clinical study management skills. Also requires excellent communication and organizational skills, along with problem solving, conflict resolution, leadership and team-building skills.
10. Manages clinical monitoring activities, ensuring compliance with Good Clinical Practices (GCP) and applicable regulations.
11. Participates in the selection, training, and evaluation of study personnel (contract and internal) to ensure the efficient operation of the function Provide input into the development of protocols and 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)
13. Develop patient education materials if needed.
14. Coordinate development of potential investigator list for a given study.
15. Ensure clinical and non-clinical supplies are available for shipment when required. Responsible for ensuring authorized sites always have supplies on hand during the treatment phase of the study.
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:
· Theoretical and working knowledge of applicable GCP and ICH guidelines as well as basic understanding of the phases of clinical development.
· Knowledge of clinical monitoring and site management.
· Strong interpersonal skills are required.
· Requires excellent written and verbal communication skills.·
· Able to multi-task and prioritize appropriately.
· Positive, team-oriented attitude.
· Requires computer literacy in several software packages, especially Microsoft Office applications and database software.
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%).
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.