Project Management

JD for Project Management / Business Development (CRO)

Roles and Responsibilities:

PRINCIPAL DUTIES AND RESPONSIBILITIES:

Note: These statements reflect the general description of the position and are not intended to be an all-inclusive list of tasks to which the employee may be assigned.

I. PROJECT RELATED ACTIVITIES:

Responsible for project management related tasks as indicated:

A. Facilitate project set-up, scheduling budgeting and release of all projects as indicated.

B. Prepare project management documentation for sponsor identification and/or approval.

C. Responsible for investigating and completing required documentation to ensure appropriate approvals are in place before execution of study.

D. Maintain and keep status on a monthly basis for all analytical methods and invitro Bioequivalence studies completed.

E. Attend teleconferences as scheduled for projects and ensure effective communication of project milestones/activities.

F. Understands time-sensitive nature of critical path project activities and notifies the relevant teams, and/or management of related issues.

G. Works with management to establish project interim milestones and ensures projects are on schedule to ensure our report structure/compilation is communicated and assist where required.

H. Working with Finance, address any discrepancies with client's invoices in a timely manner.

I. Demonstrates well-developed project management skills by utilizing the relevant information, project management methodologies and processes to assist in planning, coordinating, and monitoring of all projects.

J. Utilizes advanced problem-solving techniques to identify root causes of problems/issues and provides suggestions for the best course of action in consultation with management.

K. Demonstrates the ability to make complex interpretation and application decisions within role capacity by utilizing protocol, Standard Operating Procedures (SOPs) and/or other tools deemed appropriate.

L. Participates in on-going educational activities to enhance own knowledge level as well as that of other team members.

M. Performs other duties as assigned by department management as training experience allows.

N. To ensure appropriate approvals/agreements are in place before execution of study.

O. On need basis, assist team members in their daily activities.

II. GENERAL DUTIES:

A. Works with Associate Director, Commercial to establish the unit strategy and furnish allocated duties on priority bases ensuring compliance with required standards.

B. Recommends, develops and participates in the development or revision of internal procedures and standards with impact to department.

C. Recognizes issues and takes appropriate corrective actions, consulting with appropriate staff as required.

D. Fosters and maintains effective working relationships with all clients and functional units within Vitely.

III. ADMINISTRATIVE DUTIES:

A. Confirms to training schedule for own position and maintains awareness of SOP content, according to company requirements.

B. Stays current with the ongoing changes in the pharmaceutical regulatory environment, i.e. FDA, GxPs, GLPs, etc.

IV. ADDITIONAL ACTIVITIES:

A. To ensure proper query response in stipulated timelines for the submitted applications in coordination with respective managers.

B. Responsible to maintain the Project tracking sheet of all the awarded/ongoing projects.

C. Responsible for generating MSS on a weekly basis.

D. Weekly meeting with all internal stakeholders for timeline/status of all ongoing/upcoming studies.

E. Any Additional responsibilities given by Head of Department / Management

V. BD Related Tasks

A. To visit sponsors for acquiring new projects and show case services

B. To attend National & International forums