PATH is an international organization that drives transformative innovation to save lives and improve health, especially among women and children. We accelerate innovation across five platforms-vaccines, drugs, diagnostics, devices, and system and service innovations-that harness our entrepreneurial insight, scientific and public health expertise, and passion for health equity. By mobilizing partners around the world, we take innovation to scale, working alongside countries primarily in Africa and Asia to tackle their greatest health needs. Together, we deliver measurable results that disrupt the cycle of poor health.
Post : Senior Clinical Research Manager, Team Lead
The Senior Clinical Research Manager, Team Lead will be responsible for oversight and staff development of several team members while also providing clinical operations leadership on designated studies. This position is also expected to lead assigned clinical operations departmental initiatives, including contributing to writing and reviewing of departmental standards, Standard Operating Procedures (SOPs), Work Instructions, and Business Practices. The ideal candidate will have prior staff supervisory experience, be an expert in duties outlined in the Clinical Research Manager Role Description, have demonstrated accountability in trial and team management, the ability to oversee and proactively drive study timelines, and are passionate about leading clinical operations initiatives, including troubleshooting challenges and assisting in standardizing team processes and procedures. This position will report to the Director of Clinical Operations under the CVIA Clinical Functional Area.
Team Management (30%)
• Provide daily leadership, supervision, guidance, and development support to Clinical Operations staff using a kind and objective management style
• Lead Work Force Planning discussions for staff under his/her supervision.
• Maintain a detailed understanding of trials, including risks to quality, assigned to staff under her/her supervision.
• Maintain a weekly trial status report.
• Identify and participate / advise on the resolution of operational compliance and logistical problems impacting trials.
• Maintain expertise of FDA regulations, ICH guidelines, in-country and regional regulations to ensure that operational activities of clinical trials adhere to GCP, FDA or equivalent as well as PATH policies.
• Provide GCP and international guideline compliance expertise and consultation to staff to effectively manage clinical studies.
• Support staff training by providing or coordinating training (e.g., GCP, Risk Management,)
• Oversee the identification of potential risks to study conduct for the studies assigned to staff under supervision and support the development of risk management/mitigation plans for clinical studies.
• Oversee clinical trial timeline development and maintenance for the studies assigned to staff under supervision with a focus on critical path activities to ensure timely study completion.
• Contribute to development and writing of Clinical Team Standards, SOPs, Business Practices, and Work Instructions.
• Embody CVIA leadership competencies: Build effective teams, communicate effectively, instill trust, drive vision and purpose, ensure accountability, be courageous.
Trial Management (70%)
• Provide overall study start-up, implementation, and close-out leadership for directly assigned study trials, including the following:
• Assume responsibilities for clinical project management components related to oversight and monitoring the progress of clinical trials according to set schedules and milestones, including demonstrating a sense of urgency in delivering on trial milestones completed with high quality and in a timely manner.
• Lead development and maintenance of clinical study timelines and clinical trial risk identification and management.
• Lead development and review of Clinical Protocols, ICFs, CRFs, SOPs and other trial related documents.
• Lead development of central ethical submission packages and annual review submissions, including version control/tracking across multiple ethics committees.
• Contribute to Scientific Merit Review packages.
• Develop and contribute to appropriate study plans (e.g., monitoring, pharmacy, data management, laboratory, manual of procedures, communication, etc.).
• Oversee of protocol implementation by reviewing progress reports from CROs, monitoring and data quality reports, and audit reports as needed.
• Identify and participate on the resolution of operational compliance and logistical problems impacting trials quality.
• Lead the maintenance, and final archiving of the Trial Master Files following ICH-GCP and PATH internal procedures, including maintaining an audit-ready state.
• Oversee procurement, import and delivery of clinical trial supplies (including Investigational Product) according to trial protocol specifications.
• Oversee development of systems for tracking specimens from point of collection to delivery to central laboratories coordination according to trial protocol specifications.
• Oversee clinical trial registry postings.
• Lead or contribute to project kick off meetings and Investigator Meetings.
• Plan and conduct domestic and international site visits to help establish trial activities and evaluate operations.
• Lead site initiation visits and ascertain site readiness for study start.
• Oversee site implementation, including establishment of recruitment/retention plans and materials, as well as tracking enrollment and visits.
• Oversee establishment and maintenance of Investigator Site File.
• Verify adequacy of site staff experience and training, coordinate additional training as needed, including GCP and Site Initiation Visits.
• Conduct and document Sponsor-level oversight or monitoring visits, as needed
• Plan and coordinate site audits, including defining, scheduling, assessing, and evaluating eventual outcomes, and supporting remedial plans.
• Oversee selection and qualification of clinical trial sites and CROs
• Manage contractual activities of clinical sites and CROs, including outlining partner roles and responsibilities and technical milestones triggering payments.
• Oversee finalization of monitoring reports and tracking of action items to completion.
• Lead study-specific meetings (including development of agendas, minutes, action items, and decisions) and maintain study-related documentation.
• Integrate seamlessly across a cross-functional study team in implementing trials on-time and with high-quality, including with project, data management, biostatistics, laboratory, CMC, medical, and regulatory leads.
• A minimum of 10 years of prior experience supporting clinical research studies across trial phases (Phase 1 to 4) and stages (start-up through close-out), including vaccine trial experience at PATH .
• At least 1-2 years experience working with an increased level of responsibility in a senior-level role
• Prior supervisory experience, strongly desired.
• Managed multiple studies from start to finish in a Sponsor or Sponsor-like Capacity, including selecting and managing vendors.
• Expertise in complex clinical trials and partner relationships.
• Clinical operations subject matter expert with ability to guide and train colleagues in procedures and theoretical and practical trial management knowledge, including expertise in the following:
* Managing trial sites and Contract Research Organizations (CROs).
* International regulatory requirements, procedures, and policies
* GCP, ICH, and other Guidance documents and policies related to clinical trial operations.
* Managing timelines utilizing SmartSheet.
* Clinical risk management.
* Adhering to policies and procedures.
• Ability to analyze information, review reports and prioritize actions.
• Ability to work well in a team environment, both as a leader and a contributor.
• Demonstrated ability to perform cross-functionally in a matrixed environment. The ability to influence the behavior of others.
• Global perspective and mindset; ability to work effectively with colleagues from other cultures and time zones.
• Proficient in Microsoft Office Suites (Outlook, Word, Excel, and Teams) required
• Strong verbal and written communication skills.
• International and domestic travel up to 15-20%.
Experience : 5+ years
Tracking Code : 10347
Location : Delhi or Mumbai, India
Industry Type : Clinical research
End Date : 30th November, 2020
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