Clinical Trial Manager

4 days ago

mumbai, India IQVIA India Full time

Job Title:: Clinical Trial Manager


Therapeutics Area Experience : Oncology therapeutics experience is a must


Job Summary:


Local Trial Management services provides local management of a clinical trial (or Medical Affairs data generation activity) in a country or countries. Services/deliverables include operational oversight of assigned protocol(s) at the country level from start-up through to database lock and closeout activities. Further, services will ensure the local trial team is delivering quality data and trial documents/records that are compliant with the assigned clinical trial protocol, company Standard Operating Procedures (SOPs), International Conference on Harmonization for Good Clinical Practice (ICH-GCP), and regulatory requirements. Partners with the Clinical Trial Assistant (CTA)/Investigator Document Assistant (IDA), Site Manager (SM) and Central Trial Manager (CTM)/Global Trial Manager to ensure overall study delivery at the country level.Associate Project Leads are an integral part of clinical trial delivery, liaising with clinical teams to improve patients’ lives by bringing new drugs to the market faster.


Essential Functions:

• Provide input in to the development of integrated study management plans with the core project team and/or sub-team.

• Accountable for assigned portion of clinical studies as per the contract while optimizing speed, quality and cost of delivery and ensuring consistent use of study tools and training materials and compliance with standard processes, policies and procedures.

• Set objectives of project sub-team(s), according to agreed upon contract, strategy and approach, effectively communicate and assess performance.

• Collaborate with other functional groups within the company where necessary to support milestone achievement and to manage study issues and obstacles.

• Monitor progress against contract and prepare/present project and/or sub-team information proactively to internal stakeholders. Support the project leader to prepare/present project and/or sub-team information proactively to external stakeholders.

• Identify risk (positive and negative) and contingencies and partner with project leader in problem solving and resolution efforts.

• Achieve project quality by identifying quality risks and issues, responding to issues raised by project sub-team members and partner with project leader planning/implementing appropriate corrective and preventative action plans.

• May serve as primary (for small projects) or back-up project contact with customer.

• Lead the efforts of a project sub-team, responsible for managing cross-collaboration of the sub-team to support milestone achievement and to manage issues and obstacles.

• Support the project leader in ensuring the financial success of the project.

• Forecast and identify opportunities to accelerate activities to bring revenue forward in partnership with the senior project leader.

• Identify changes in scope and partner with project leader to manage change control process as necessary.

• Identify lessons learned and implement best practices.

• May be assigned as the primary contact for vendors leading project vendor management and vendor management related activities as per project requirements


Qualifications:

• Associate's Degree In life sciences or related field required Req Or

• Bachelor's Degree In life sciences or related field required Req

• 7+ years clinical research experience. Req

• Requires intermediate level knowledge of principles, theories, and concepts of a job area, typically obtained through advanced education combined with experience.; Req

• Knowledge of clinical trials - Knowledge of clinical trial conduct, and skill in applying applicable clinical research regulatory requirements i.e. ICH GCP and relevant local laws, regulations and guidelines, towards clinical trial conduct. Broad protocol knowledge, therapeutic knowledge desired.;

• Communication - Strong written and verbal communication skills including good command of English language. Strong presentation skills.

• Problem solving - Strong problem solving skills.

• Organization - Planning, time management and prioritization skills. Ability to organize resources needed to accomplish tasks, set objectives and provide clear direction to others, experience planning activities in advance and taking account of possible changing circumstances.

• Prioritization - Ability to handle conflicting priorities.

• Quality - Attention to detail and accuracy in work. Results-oriented approach to work towards delivery and output.

• IT Skills - Good software and computer skills, including MS Office applications including but not limited to Microsoft Word, Excel and PowerPoint.

• Collaboration - Ability to establish and maintain effective working relationships with coworkers, managers and clients. Strong customer service skills.

• Cross-collaboration - Ability to work across geographies displaying high awareness and understanding of cultural differences.

• Finances - Good understanding of project financials.

• IQVIA Core Competencies - Ability to demonstrate all IQVIA competencies (Client Focus, Collaboration, Communication, innovation, Ownership).

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