Job Description
The (Sr.) Clinical Trial Manager (CTM) is responsible for supporting the effective planning and conduct of one or more ADARx Pharmaceuticals clinical trials in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP and applicable regulatory requirements.
Responsibilities
- ✓Clinical operations functional activities related to the execution of assigned clinical trials based upon department and corporate goals and objectives.
- ✓Proactive management of clinical studies and vendors to ensure studies are completed on time, within budget and in compliance with Standard Operating Procedures (SOPs), FDA regulations and International Council for Harmonization (ICH)/ GCP guidelines.
- ✓Ensure the successful execution of clinical trial activities with the study team, clinical CROs and other clinical study providers (e.g., core labs, independent contractors) on time, with pre-approval inspection readiness and on budget.
- ✓Generate and utilize metric reporting (e.g., CTMS, DM Query Trends, Outstanding Monitoring Reports) to ensure that the study is conducted per plan and communicate issues to Team Members/Vendors, with escalation as appropriate.
- ✓Maintain and report metrics for trial tracking and clinical site performance, including site activation, patient enrollment and retention.
- ✓May perform clinical data review of patient profiles, data listings and summary tables, including query generation.
- ✓Develop and/or provide input to trial plans, such as Project Management Plan, Enrollment Plan, Monitoring Plan, Study Guides/Manuals, Protocol Deviation Plan, Timelines, etc.
- ✓Develop, review and/or provide input to patient information/consent/assent, eCRF forms and completion guidelines, pharmacy manual, site instructions and study forms/site binders, etc.
- ✓Review and/or approve of IP release packages.
- ✓Review monitoring reports and other study documentation as required including tracking of such to align with visit forecasting for data centered monitoring.
- ✓Oversight of the collection, provision of documents, and management of clinical trial document filing in the Trial Master File (TMF) and QC.
- ✓Participation in team meetings and collaborate with other functional groups within the company and project team (e.g., Medical, Data Management, Regulatory, QA, Finance, Legal, etc.) to achieve clinical study goals.
- ✓Follow up on assigned team action items and identification, escalation, and resolution of issues.
- ✓Collaboration with contracts specialist/Legal to review and negotiate Clinical Trial Agreements and review of site-specific study budgets.
- ✓Assessment of adequacy/feasibility of potential clinical investigators and sites including evaluating facilities, personnel, patient referral base, and adherence to GCP.
- ✓Oversee vendor site visits, and may conduct site visits (e.g., training visits, site initiation visits, monitoring visits), if required.
- ✓Manage investigational product accountability and reconciliation process in conjunction with CMC/RTSM.
- ✓Assist with/review of safety, interim and final clinical study reports, and resolution of data discrepancies.
- ✓Provide clinical trial support, mentoring, leadership, guidance, and direction to others assigned to the project(s).
- ✓Serve as primary clinical operations contact for internal and external (clinical sites, vendors, etc.) teams for assigned studies.
- ✓Review protocol deviations, risk, issues and any other data/trackers/listings.
- ✓Support safety reporting in conjunction with vendor/pharmacovigilance.
- ✓Support the management, tracking and oversight of clinical site budgets/payments in relation to conduct of a clinical trial.
- ✓Manage IRB/IEC and regulatory submissions, as needed.
- ✓Establish vendor management plans and review quality metrics.
- ✓Other duties as assigned.
Qualifications
- ✓BA/BS in life and health sciences (biology, pharmacology, pharmaceutical sciences or equivalent experience)..
- ✓8+ (10+ for Sr.) years of managing Phase 1-3 clinical trials at biotech/pharmaceutical and/or CRO.
- ✓Ability to work across global time zones (including EU, APAC).
- ✓Experience in performing clinical site monitoring visits, including remote visits, preferred.
- ✓Experience in CRO/Vendor management (domestic/international).
- ✓Comprehensive knowledge of ICH, GCP, IRB/IEC, and local regulatory authority requirements.
- ✓Proficiency working with Microsoft Office Suite Products, EDC, RTSM, CTMS, eTMF.
- ✓Ability to timely read, manage, respond and use of email for efficiency and communication.
- ✓Ability to travel domestically and internationally if necessary.
- ✓Understanding of project timelines and deliverables and plan/coordinate project work accordingly with departmental, functional, and external stakeholders.
- ✓Global clinical trial experience preferred.
- ✓Small to mid-size biotech/pharmaceutical experience preferred.
Required Key Attributes
- ✓Must be able to work independently as well in cross-functional team settings with minimal supervision as needed.
- ✓Excellent written and verbal communication skills.
- ✓Strong problem-solving skills and a proactive attitude
- ✓Understanding of project timelines and deliverables and plans/coordinate project work accordingly with departmental, functional, and external stakeholders.
- ✓Adaptable / Flexible - willing and able to adjust to multiple demands and shifting priorities as well as an ability to meet day-to-day challenges with confidence and professionalism.
- ✓Self-motivated with excellent interpersonal, organizational and communication skills with the ability to take a hands-on approach to work effectively in a dynamic and collaborative, fast-paced environment.
ADARx Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.