Manager- Statistical Programming Bengaluru,Karnataka,India 12 - 14 years INR Not disclosed On-site Full Time

Broad Purpose Avance Clinical is a Contract Research Organisation which offers specialised services supporting drug development for the pharmaceutical and biotechnology industry. Manager, Statistical Programming is responsible for the oversight of statistical programming operations and team, and for reporting to Associate Director, Statistical Programming. Core Responsibilities Ensure a high level of client service is delivered and maintained in terms of deliverables and timelines, whilst also delivering projects within budget. Ensure statistical programming team deliverables consistently meet study timelines, quality standards and contractual requirements. Implement effective tracking and reporting to monitor staff workload and optimize staff utilization. Provide a strong, cohesive link between the Statistical Programming Team and Biometrics (i.e. Statistics and Pharmacokinetics) and Data Teams ensuring clear and defined communication pathways are established. Report regularly to the Associate Director, Statistical Programming in respect to Statistical Programming group operations, resourcing, system issues, project performance and potential project slippages. Provide considered justification statements to the Associate Director, Statistical Programming relative to resource expenditure. Monitor projects against milestones and budget. Provide leadership in issue resolution with external parties, i.e. clients and external vendors and auditors. Identification and remediation of issues arising that may affect the planned completion of client projects including provision of support, guidance and assistance (when necessary) to Statistical Programming staff to meet project milestones. Provide extensive technical and managerial leadership, including mentorship and training of direct reports; delegate responsibilities appropriately with the target of continuously developing team capabilities. Participate in the development and refinement of global statistical programming standards, as well as supporting best practices and process improvement initiatives across the department. Facilitate communication between all project stakeholders and ensure that regular updates are provided in accordance with each study plan. Participate in client meetings and Audits as required. Other duties as directed by Line Management or delegate in line with skills, experience and/or qualifications. Departmental Responsibilities In consultation with stakeholders, initiate the development of team members via training, programming process improvements. Ensure there is ongoing quality review within the departments as required, including internal reviews of documents and forms to ensure they are appropriate for use. Ensure appropriate allocation of team resources to client programs to ensure timely delivery of activities, monitor individual workloads and ensure staff keep task lists current. Manage recruitment, training, human resource and performance management for the Statistical Programming Team. Quarterly review of staff training files to ensure compliance with Standard Operating Procedures (SOPs) and to maintain staff development. Monitor adherence to guidelines and policies. Qualifications, Skills and Experience Minimum 12 years experience in the pharmaceutical industry / CRO working in clinical project management. Proven experience in different phases and therapeutic areas of clinical trial programming. Possess excellent interpersonal and communication skills. Can build and maintain positive relationships with management, peers, and subordinates. Ability to work independently or in a team environment as needed. Display strong analytical and problem-solving skills. If the above opportunity interests you then please e mail your CV to [HIDDEN TEXT] Show more Show less

Clinical Data Manager karnataka 2 - 6 years INR Not disclosed On-site Full Time

As a Clinical Data Manager I at Avance Clinical, you will be responsible for performing activities associated with the Data Cleaning activities of Clinical trials to ensure that the trials are conducted in accordance with the protocol, company Standard Operating Procedures (SOPs), ICH GCP guidelines, and other applicable regulatory requirements. Your core responsibilities will include autonomously developing study-related documents or plans, leading the Data management team as the Lead CDM, raising data queries in the EDC, ensuring accurate and timely filing as per SOP requirements, maintaining effective communication across the study team, participating in study-specific or vendor audits, and ensuring Serious Adverse Events are reported as per protocol requirements. In addition to your role-specific responsibilities, you will also be expected to foster a healthy team culture, maintain effective communication with other members of the department, proactively identify risks related to departmental service provision, participate in internal Quality Assurance activities, and embrace the core values of Avance Clinical. To qualify for this role, you should have a Bachelors level degree in life sciences, pharmacy, nursing, or equivalent field, at least 2 years of previous experience as a CDM in a Contract Research Organization (CRO) or Pharma company, formal ICH GCP training, a working knowledge of ICH GCP Guidelines and other applicable regulatory requirements, effective communication skills, ability to take initiative in problem-solving, and willingness to work in a positive and dynamic team culture. Avance Clinical offers a stimulating work environment, project diversity, an intellectual challenge, an agile & flexible workplace, opportunities for progression, stability, a sense of community, a leadership team that works together on a common goal, flexible work options, and great tools/tech to support you in your role. If you are a likeminded individual looking to join a growing business like ours, we invite you to submit your CV & cover letter as one Microsoft Word document to be considered for this exciting opportunity at Avance Clinical.,

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