General Manager - Clinical Research - Pharma

Reports to: Vice President - Clinical Research

Job Overview:

We are looking for General Manager - Clinical Research to manage clinical operation and interpret clinical trial data and market research. Plans, develops, and manages the clinical trials and associated administrative activities of a large, complex medical research study or group of studies. Supervises medical, pharmaceutical, biomedical and/or technical research support staff engaged in the carrying out research through clinical trial protocol. Develops budgets, operating procedures, and funding mechanisms, and coordinates the procurement and management of required resources, sites, hospitals, CRO, SMO, other clinical research vendor's, facilities, equipment, and materials.

Job Responsibilities:

- Participates in and coordinates the planning, development, and implementation of clinical protocol, administrative and logistical procedures, documentation, and operating systems, in accordance with research parameters set out by the principle investigator.

- Recruits, supervises, evaluates, and coordinates the activities of a team of professional pharma and/or clinical research support staff; ensures that all clinical activities are carried out in accordance with established research protocol, and with acceptable clinical procedure and safety standards.

- Assesses operational, financial, and materials requirements for the study and prepares operating budgets; plans and coordinates the procurement of required clinical facilities, equipment, and supplies.

- Plans and carries out programs for the recruitment, screening, enrolment, and retention of clinical research subjects and/or volunteers; instructs research subjects on treatment methods and protocol and on the proper administration of drugs and other treatment aids.

- Establishes appropriate data collection systems and procedures, according to pre-established research protocol; coordinates and monitors the collection, processing, and recording of clinical data and/or specimen samples, as required by established study protocol.

- Oversees the planning, scheduling, and carrying out of day-to-day clinical activities and procedures, ensuring efficient workflow and adequate care and treatment of research subjects.

- Develops and/or coordinates the maintenance of records on medication dispensation and inventory usage during the study; ensures confidentiality of subject records.

- Monitors and records patient response to treatment and communicates study data and results to investigators; maintains complete source documentation and oversees the preparation of study activity reports for sponsors and various medical, legal and regulatory bodies, as appropriate.

- Provides consultation, liaison, and administrative coordination between investigators and ancillary departments, research subjects, sponsoring organizations, and/or regulating bodies; identifies and addresses problems, facilitates audits, and corrects deficiencies.

- Participates in the identification of potential research funding sources, and in the development and writing of grant proposals and project plans.

- Represents and promotes the objectives and activities of research studies to various internal and/or external constituencies, as appropriate.

- Performs miscellaneous job-related duties as assigned.

- Experienced in clinical operation.

- Vendor management and Coordination with F&D, manufacturers of final formulations for CT

- Exposure in interpreting clinical trial data and market research

- Interact with different departments like FND, Biological R&D, regulatory, finance and audit teams and external vendors like clinical labs, hospitals, DM and statistics services provider, publication houses.

- Ensuring compliance with Scientific engagement principles and standards in all activities and ensure that all governance activities are managed proactively.

Skills:

- Clinical research department management for clinical operation.

- Clinical study report and manuscript finalization.

- Regulatory audit compliance.

- Ability to develop and deliver presentations.

- Knowledge of accreditation and certification requirements and standards.

- Strong interpersonal and communication skills and the ability to work effectively with a wide range of constituencies in a diverse community.

- Ability to observe, assess, and record symptoms, reactions, and progress.

- Ability to maintain quality, safety, and/or infection control standards.

- Skill in the use of personal computers and related software applications.

- Knowledge of the principles and procedures of clinical research.

- Records maintenance skills.

- Skill in budget preparation and fiscal management.

- Knowledge of human resources concepts, practices, policies, and procedures.

- Knowledge of inventory management practices.

- Skill in organizing resources and establishing priorities.

- Knowledge of drugs and their indications, contraindications, dosing, side effects, and proper administration.

- Knowledge of contracts and grants preparation and management.

- Ability to design and implement systems necessary to collect, maintain, and analyze data.

- Ability to supervise and train employees, to include organizing, prioritizing, and scheduling work assignments.

- Ability to make administrative and procedural decisions and judgments on sensitive, confidential issues.

- Knowledge of cGCP, cGMP and regulatory requirements pertaining to the drug and nutraceutical trials.

- Ability to recruit, evaluate, and instruct clinical research subjects and volunteers.

- Ability to manage laboratory samples analysis and its interpretation using established protocols.

Education and Experience:

- M.Pharmacy/Ph.D in Pharmacy

- 10-15 years with prior experience in similar field.