MedFocus Clinical Trial Operations Mgr III (CEP) in New Jersey
Job Description: A Clinical Trial Operations Manager III is needed for a contract position at major pharma company.
The Clinical and Exploratory Pharmacology (CEP) Clinical Trial Manager (CTM) is responsible for the overall operational planning and activities for the implementation and conduct of clinical exploratory pharmacology clinical trials in compliance with ICH, GCP’s, SOPs, local requirements, internal/departmental guidelines, and established timelines. The CTM is involved in the operational planning and scientific conduct of the clinical trial and acts as the leader of operational disciplines (Clinical Trial Team (CTT)) to guarantee release of homogeneous high quality clinical data in close collaboration with the CEP Data Manager (DM) and Clinical Study Director (CSD).
The CTM may manage studies at the product level (if applicable). The CTM can be involved in field monitoring activities of his/her own studies according to workload/need and/or manages local monitoring or outsourced monitoring. The CTM may also participate in intra or inter-department Working Groups.
The job may include international responsibilities.
Duties and Responsibilities:
Provide management and oversight of clinical trials (which may include complex, multiple center and multinational proof-of-concept studies) to ensure progress according to study timelines.
Lead the Clinical Trial Team (CTT) including representatives of all operational disciplines involved in the conduct of trial (i.e., CRAs/CROs, Data Management, Pharmacovigilance, Clinical & Exploratory Pharmacology Sciences, Biostatistics, Pharmacokinetics, Clinical Supplies, and other relevant departments, platforms or units).
Manage the study according to Good Clinical Practices (GCPs) and local and/or national regulations, with responsibilities on product and project level.
Collaborate with team members on a day-to-day basis; in particular, build a strong collaboration with the study Data Manager (DM) and the Clinical Study Director (CSD).
Anticipate bottlenecks in all steps of the study and development/implementation of counteractive measures
Solve or coordinate the resolution of issues during conduct of the trial
Develop and review specific study-related documents
Develop and coordinate the study budget, including invoice validation
Contribute to contract process
Manage investigational product supplies (ordering, packaging, and shipment)
Participate in and contribute to internal audits, if applicable
Serve as main contact for clinical sites and other outsourced activities
Manage local MT (CSUs) when applicable
Manage outsourced centralized activities when applicable (Central Lab)
May perform studies following some Phase 2-3 processes when applicable (multicenter-multicountry Phase 2a trials)
Collect, synthesize, report, file and prepare archiving for clinical trial activities
Management of CRO
Manage CRO/study sites
Escalate quality issues and delays in deliverables, propose solutions, request and ensure follow-up actions
Assess CRO performance by completing CRO post services assessments
Conduct yearly CRO assessment, if applicable
Manage outsourced/sub-contracted monitoring activities, when applicable.
Lead study-specific training
Manage performance of monitors
Review and approve all visit reports
Conduct field monitoring activities, if required
Set-up and manage site visits (Site Initiation Visit, Interim Monitoring Visits, Closure Visit) including in-house preparation such as data listings review
Attend site visits as primary or co-monitor (e.g. when mentoring Associate CTMs)
Conduct source data validation and other monitoring activities (according to the study-specific Monitoring Plan, if applicable)
Use eCRF tool for ongoing data review and query generation
Regularly review and reconcile the Investigator Study File, Investigational Product accountability and biological sample management
Report visit progress/findings to CSD and other relevant members of the CTT and Site manager
If applicable, review visit reports
Participate to the mentoring and training/coaching of Associate CTMs, apprentices or trainees
Utilize department mentoring program
Track mentoring/training progress by meeting with mentee on regular basis
Participate in intra or inter-department Working Groups, if applicable
Propose and implement process improvements
Participate in development/improvement of guidance documents
Other leadership activities:
May serve as internal consultant for specific departmental activities, if applicable
May serve as Project leader for the department or external to the department: be the referent for a specific compound and maintain accurate documentation available for the department, participate in Project Team meetings, if applicable
Negotiating effectively with all CTT functions and achieving common agreement. Each function has competing priorities and timelines and it is difficult to achieve alignment with the CTT goals and functional goals.
The CTM ensures alignment across the CTT functions and manages effectively the different providers to ensure delivery of study milestones.
Key Internal and External Relationships
Internal contacts: CEP-OP Site Manager, CEP-OP Senior Site Coordinator, CEP-OP Expert Data Management Coordinator, CEP CTM(a)s, CEP DMs, CEP CSDs, CEP DPEs
External contacts: CSO SCP departments (including Biostatistics, Clinical documentation, CSO project leaders), other platforms (e.g. DSAR, Supply Chain), Units project leaders, Clinical Study Units (CSUs)/affiliates if applicable, Regulatory, Pharmacovigilance, Finance, Legal, Clinical Purchasing, other partners external to R&D; (e.g. Industrial Affairs)
Outside the company: Clinical Research Organizations (CROs), clinical trial vendors (e.g., ECG central readers), Academic Research Organizations, External Steering Committee Members, Data Monitoring Committee members, Key opinion leaders & medical advisors if applicable.
The CTM should make study logistic decisions in conjunction with the CTT and may need to consult with the Site Manager for operational issues that could affect study/program timelines or quality.
The CTM, in collaboration with CEP management, should release/distribute outcomes (new guidelines, processes) from Working Groups, when applicable.
The CTM is planning the Global Study schedule as well as his/her own travel schedule for monitoring purpose, in conjunction with the Data Manager and CTM(a) when applicable.
During monitoring visits, monitors have direct access to subject individual data for records review. Monitors are bound by professional secrecy and as such will not disclose any individual identity and/or individual medical information.
Education and Experience:
Bachelor's Degree + 8+ yrs. laboratory or medical experience
5+ years in clinical research
Field monitoring experience or related experience is required (approximately 3-5 years).
Strong English communication skills (verbal and written) if English is a second language.
Clinical Trials Management or Project management experience (approximately 3-5 years) and recognized in cross functional operations. Knowledge and Skills:
Previous experience with medical terminology (basic knowledge in medicine is preferred, including laboratory procedures/techniques and biological knowledge) and GCP/ICH Guidelines
General understanding of R&D; processes including the principals of study design and execution
Capability of interacting effectively with scientists and managers from various disciplines on an international basis
Ability to serve as internal consultant on assigned area and liaise with external organizations on projects
Good interpersonal and communication skills (verbal and written)
Self-motivation, flexibility, attention to detail and organizational skills, goal-oriented
Ability to build optimal collaboration within the company and with external partners
Ability to work in a team environment
Project Management skills
Experience with various computer systems/database; a willingness to learn new systems/databases
Ability to prioritize activities
Results-driven in terms of timelines and quality Desired, but not required Knowledge and Skills:
Previous Phase I experience preferred
Knowledge of data management activities
Experience with management of outsourced activities
Please send resume to email@example.com
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