Job Description

Roles and Responsibilities

Primary Purpose :

The PM will be responsible for the management of several key PM Knowledge Areas.

The scope of these duties will span all phases of the project: Initiation, Planning, Execution, Controlling, and Closing. The job will support the Project Director (the Clinical Research/Project Manager), the Project Team and Project Leadership.

Responsibilities :

- Liaison with the study sponsors and the collaborating investigators to prepare and initiate clinical protocols.

- Oversee and conduct data management and related communication processes for the clinical trials studies.

- Work with the study statisticians to prepare statistical and safety reports.

- Additional tasks include, but are not limited to, development, review, and approval of protocols, eCRF, study documents, and reports such as SMC, IND, and CSR.

- Key role as team leader in project planning, implementation, problem solving, tracking milestones, and deliverables.

- Ensures project timelines are not at risk and/or escalates impediments to internal team proactively, prior to any lapse; facilitates internal team plan for resolution.

- Involved in bid defense meeting and putting the bid together and involved in budgeting exercise.

- Ensure optimum utilization and allocation of team budgets basis clinical study requirements.

- Assists in drafting study progress reports required for clinical research studies and projects, review reports and contribute sections, as appropriate.

- Provide data management and operational support activities for a protocol or group of protocols.

- Possess detailed knowledge of the protocol/s. Collaborates with project teams to identify data collection requirements based on a study protocol. Develop electronic case report forms (eCRFs) and perform user acceptance testing (UAT).

- Review, implement, and evaluate data validation processes; Develop and update study and project materials, including electronic case report forms (eCRFs), Manual of Operating Procedures (MOPs), EDC System User's Guides, Data Management Handbooks, Data Management Plans, Data Validation Plans, project specific Standard Operating Procedures (SOPs) and work instructions; distribute anomaly reports and resolve data discrepancies.

- Participate in site update calls and sponsor calls, as needed.

- Support project statistician to review project-specific reports, as needed.

- Create and maintain documentation on all data-related activities in alignment with project-specific and corporate SOPs.

- Participate in corporate QA meetings with the Internal Quality Audit Team (IQAT), ensure adherence with Corporate, project-specific, and client (as applicable) SOPs and compliance/variance table, and participate in internal/external audits, as required. Ensure adherence to GCP and ICH guidelines.

- Provide training for internal and external stakeholders on company's EDC systems and data management practices.

- Performs internal data audits and other project quality assurance activities and documents processes as required by corporate/project SOPs.

- Reviews project required reports and contributes to sections as appropriate.

- Demonstrates an understanding of project and corporate SOPs.

- Assists with the orientation of new personnel and serves as a mentor for junior staff.

- Manages staff productivity and development, conducts periodic review meetings and documents annual performance.

Experience :

- Requires degree and a background in public health, biological sciences, or related fields 8-14 years of experience in clinical trials with a solid understanding of clinical trial databases.

- Proven supervisory skills and excellent verbal and written communication skills.

- Infectious disease/Vaccine domain knowledge and DCGI-related experience a plus.

- SAS proficiency, familiarity with CDISC, and experience with site monitoring, training, and selection a definite plus.

- Preparing the bids & participating in bid defense meetings.

- Involved in budgeting exercise

- Resource allocation & tracking.

- Ability to manage multiple tasks.

- Ability to work independently, as well as in a team environment.

- Ability to effectively communicate technical concepts, both written and oral.

- Ability to lead / drive departmental initiatives.

- Ability to supports recruitment activities in terms of interviewing candidates