R&D Clinical Trial Support Manager

Job title: R&D Clinical Trial Support Manager

• Location: Hyderabad

About the job

Clinical Trial Support Manager (CTSM) supports the clinical study leader in execution and delivery of clinical studies. The CTSM is responsible for the activities that will be delegated to her/him including the preparation of study related plans and materials, appropriate escalation of issues, identification of study risks and contingency planning, monitoring of the study plan, and support of the clinical study leader in the overall management of budget tracking and invoice approval.  In some cases, there might be a need to support some vendor activities. The CTSM acts with critical thinking and problem-solving mindset and executes her/his tasks with integrity and suitable for regulatory review.The study leader will have oversight of the CTSM activities.

Main responsibilities include:

Ensure proper study documentation/availability, Develop / contribute with study team members all required study documents as per SOP including but not limited to the Study Risk Management Plan (SRMP), Monitoring Plan (MP), Study Communication Plan, Training Material, recruitment and retention plan, Who’s who and study operational materials including memos, study newsletters

Review study team-developed documents as per SOP, such as study id card, protocol, amendments, WSI, eCRF (Case Report Form) and completion guidelines, Centralized Monitoring Plan, committee charters and/or other operational documents as requested to provide operational input.Ensure study documentation is properly maintained and archived in the Trial Master File (TMF) and relevant Sharepoint locations as required.

Develop and manage the study budget under supervision:

Support the study leader in preparing the overall study budget and tracking expenditures against it. 

Supporting quarterly forecasts and following expenses / accruals, identify and evaluate complementary needs.

Perform final budget reconciliation with vendors at study end.  

Organize and lead under supervision study specific meetings:

Organize, participate and lead under supervision the study team meetings to support the study leader in execution of the studies.

Organize, participate and lead under supervision the meetings with Clinical Operations Study Country Leads (COSCL) to oversee study progress if needed.

Participate and support the training of the monitoring team, investigator meetings.

Organize and lead under supervision the meetings with vendors (for vendors in his/her scope) if needed.

Contribute to data cleaning, data review, RBM and data driven monitoring strategy meetings.

Support Vendor management

Oversee activities and deliverables when activities are outsourced to vendors to ensure performance expectations are met.

Follow-up of the associated budget and ensure tracking payments for operational aspects of the study in collaboration with the clinical buyers.

You will work closely with the translational medicine team and clinical development team to create and execute the clinical sample management plan for the clinical study. You will be accountable for all operational/logistic samples related topics within the Study Team and the different labs vendors involved in the study.

Monitor/Oversight of the samples collection, reception and analysis (including samples tracking and regular Samples ID reconciliation), managing issues resolution in a timely manner with a proactive mindset and escalate as necessary, documenting in parallel.

Investigational Medicinal Product (IMP) Management:

support in validating IMP needs, shipment (including resupply) and reconciliation process.

Pre-Approval Inspection (PAI) activities:

participate in preparation of audits and contribute to elaborate proper responses to audit / inspection reports for finding associated to study leader.

Communicate with study team members to develop and implement immediate action plans if needed.

Upon request, prepare and assist in PAI preparation plan with the PAI project team. Utilize designated tools developed to oversee quality (e.g. CTMS reports, PAI Tools kit) for an Inspection-readiness approach.

About you

• Bachelor’s degree (advanced degree preferred, degree in scientific discipline preferred) and at least 6 to 8 years of experience in clinical operations and managing clinical studies

• Basic knowledge of clinical development, GCP & ICH guidelines, regulations by major regulatory bodies such as FDA (Food and Drug Administration) and EMA (European Medicines Agency), and SOPs/ QDs.

• Demonstrated ability to work efficiently with clinical study leader within the same project, ability to collaborate with cross-functional team members and external partners using collaborative negotiation skills

• Ability to anticipate potential issues, proactively identify ways to resolve/mitigate, timely escalate with appropriate action plans Readily adapt to new environment, technologies and processes (e.g. new digital tools)

• Good organizational skills: ability to multi-task, skill in establishing priorities and meeting deadlines

• Ability to work autonomously, Strong written and verbal communication skills.

• English language skill: ability to exchange fluently (incl. negotiation), lead international meetings, write meeting minutes/ emails/ study documents, internal & external communications.

Pursue progress, discover extraordinary

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