Principal Investigator

Conducts all clinical trials (studies) according to ICH GCP, local regulations, study protocol and company processes. Ensures the medical wellbeing and safety of the participants through the safe performance and execution of the studies. Drives clinical oversight and quality of the studies at the site, or with PI oversight at other sites. Works as part of a team, with focus on positive interactions with sponsors, clients and staff members at the site. Participates and engages in driving delivery of study targets, thereby contributing to the commercial success of the site which includes: recruitment, enrolment and retention of study participants. Focuses on own development of skills and expertise and assists with training, mentoring and general support to junior physicians. Generally takes on a more active role giving input into the site processes and sharing best practices gained form years of experience. Manages and oversees various studies simultaneously with the responsibility of PI and sub-I.

Essential Functions and Other Job Information:

· Carries out clinical evaluation and assessment of participants to ensure eligible participants are recruited and monitored for safety and adherence.

· Attends Site Initiation Visits (SIV), Pre-Selections Visits (PSV) and Investigators meetings as required.

· Participates in recruitment initiatives and strategy development to ensure targets are achieved; ensuring recruiting studies enroll according to plan within timelines and targets.

· Reviews enrollment progress, pre-screening and screening success rates, screen failure rates, safety and retention of participants.

· Interprets protocols and IB.

· Manages and reviews IVRS, CRF/EDC, if applicable.

· Oversees management of investigational medical product (IMP).

· Identifies and reports trends within studies to manage it in light of conduct and outcome.

· Oversees multiple studies and/or studies with higher numbers.

· Cares for and protects the safety of participants through ethical conduct, this should receive the highest priority at all times during all aspects of the study

· Fulfills and complies with all medical duties, ensuring that clinical trials are performed to acceptable medical, scientific and ethical standards and meet the requirements as per protocol, SOP/COP ICH and local GCP guidelines and regulations.

Conducts all clinical trials (studies) according to ICH GCP, local regulations, study protocol and company processes. Ensures the medical wellbeing and safety of the participants through the safe performance and execution of the studies. Drives clinical oversight and quality of the studies at the site, or with PI oversight at other sites. Works as part of a team, with focus on positive interactions with sponsors, clients and staff members at the site. Participates and engages in driving delivery of study targets, thereby contributing to the commercial success of the site which includes: recruitment, enrolment and retention of study participants. Focuses on own development of skills and expertise and assists with training, mentoring and general support to junior physicians. Generally takes on a more active role giving input into the site processes and sharing best practices gained form years of experience. Manages and oversees various studies simultaneously with the responsibility of PI and sub-I.

Essential Functions and Other Job Information:

· Carries out clinical evaluation and assessment of participants to ensure eligible participants are recruited and monitored for safety and adherence.

· Attends Site Initiation Visits (SIV), Pre-Selections Visits (PSV) and Investigators meetings as required.

· Participates in recruitment initiatives and strategy development to ensure targets are achieved; ensuring recruiting studies enroll according to plan within timelines and targets.

· Reviews enrollment progress, pre-screening and screening success rates, screen failure rates, safety and retention of participants.

· Interprets protocols and IB.

· Manages and reviews IVRS, CRF/EDC, if applicable.

· Oversees management of investigational medical product (IMP).

· Identifies and reports trends within studies to manage it in light of conduct and outcome.

· Oversees multiple studies and/or studies with higher numbers.

· Cares for and protects the safety of participants through ethical conduct, this should receive the highest priority at all times during all aspects of the study

· Fulfills and complies with all medical duties, ensuring that clinical trials are performed to acceptable medical, scientific and ethical standards and meet the requirements as per protocol, SOP/COP ICH and local GCP guidelines and regulations.

Qualifications:

Education and Experience:

• A valid medical degree within the country of practice with at least 3 years working as a licensed physician, as well as other medical licenses as may be required within the country (e.g. dispensing license)

• Valid registration as a medical practitioner, with a medical license in good standing and with unrestricted ability to practice in place of work, where applicable

• At least 3 years’ experience working in clinical research with sufficient PI responsibility

• A valid ICH GCP certificate

• Exceptional general medical practitioner diagnosis and treatment proficiency

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:

· Exceptional understanding of medical terminology, drug safety, and interpretation of lab reports

· Thorough understanding of scientific concepts related to the design and analysis of clinical trials

· Excellent written, verbal and presentation skills

· Capable of working well under pressure

· Capable of effectively prioritizing and managing multiple projects

· Strong planning, organizational and project management skills

· Capable of managing outside agencies in order to fulfill project objectives

· Self-starter with ability to thrive under pressure in a fast paced environment

· Skilled in Word, Excel, and PowerPoint and proficient with the Internet

· Displays strategic leadership by influencing the site team to deliver on targets

Qualifications:

Education and Experience:

• A valid medical degree within the country of practice with at least 3 years working as a licensed physician, as well as other medical licenses as may be required within the country (e.g. dispensing license)

• Valid registration as a medical practitioner, with a medical license in good standing and with unrestricted ability to practice in place of work, where applicable

• At least 3 years’ experience working in clinical research with sufficient PI responsibility

• A valid ICH GCP certificate

• Exceptional general medical practitioner diagnosis and treatment proficiency

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:

· Exceptional understanding of medical terminology, drug safety, and interpretation of lab reports

· Thorough understanding of scientific concepts related to the design and analysis of clinical trials

· Excellent written, verbal and presentation skills

· Capable of working well under pressure

· Capable of effectively prioritizing and managing multiple projects

· Strong planning, organizational and project management skills

· Capable of managing outside agencies in order to fulfill project objectives

· Self-starter with ability to thrive under pressure in a fast paced environment

· Skilled in Word, Excel, and PowerPoint and proficient with the Internet

· Displays strategic leadership by influencing the site team to deliver on targets