Director Clinical Projects Jobs Vacancy in Mcr
Mcr urgently required following position for Director Clinical Projects. Please read this job advertisement carefully before apply. There are some qualifications, experience and skills requirement that the employers require. Does your career history fit these requirements? Ensure you understand the role you are applying for and that it is suited to your skills and qualifications.
Follow the online directions, complete all the necessary fields, and provide all relevant information so your application is submitted correctly. When you click the 'Apply this Job' button (open in new window) you will be taken to the online application form. Here you will be asked to provide personal and contact details, respond to employment-related questions, and show how you meet the key selection criteria.
Director Clinical Projects Jobs Vacancy in Mcr Jobs Details:
CPT - CBD
- Market Related
The Director, Clinical Projects is responsible for the planning, implementation, conduct, and reporting of clinical research projects in accordance with Good Clinical Practice (GCP) guidelines, Good Laboratory Practice (GCLP) guidelines, Good Pharmacy Practice (GPP) guidelines, International Conference on Harmonization (ICH) guidelines and company standard operating procedures (SOP’s)
Job Description and Job Specifications
Job Title: Director, Clinical Projects
Reports To: Chief Medical Officer/Executive Director Clinical Affairs
Supervises: Clinical Operations Team
Location: Western Cape
Job SummaryThe Director, Clinical Projects is responsible for the planning, implementation, conduct, and reporting of clinical research projects in accordance with Good Clinical Practice (GCP) guidelines, Good Laboratory Practice (GCLP) guidelines, Good Pharmacy Practice (GPP) guidelines, International Conference on Harmonization (ICH) guidelines and company standard operating procedures (SOP’s) and processes. This person will be responsible for managing all aspects of the clinical project team as well as various consultants, vendors and Clinical Research Organizations (CROs).
The general areas of responsibility include but not limited to: project planning, initiation, implementation and management; conduct of clinical and epidemiology research projects; resource procurement and planning; monitoring project progress according to quality standards; SOP’s, ICH and/or other guidelines to fulfill local, country and global guidelines and regulations; milestone planning and tracking; project progress reports and management.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily:
- Lead, manage day-to-day activities and provide strategic direction to the clinical project team;
- Oversee planning, management and reporting of investigator meetings, advisory boards and other scientific committees as required by the protocol (e.g. independent reviews, DSMB’s, etc.) in close coordination with other clinical affairs teams;
- Collaborate in the design of the clinical development plans with protocol synopses for assigned project;
- Representing the clinical project management team on product development teams and cross-functional teams;
- Assure regulatory requirements, International Conference on Harmonization (ICH) guidelines are met prior to study initiation and during study conduct;
- Development of a project communication plan
- Risk management
- Oversee documenting and reporting of project activities through status reports
- Oversee maintenance of the TMF/TSFs.
- Manage and track project progress according to schedule, budget and quality requirements, pro-actively identify risks and implement corrective and preventative actions as required
- Manage relationships with and performance and delivery of vendors and Clinical Research Organizations;
- Assessment of quality through co-monitoring visits and Research Centre visits
- Coordinate CAPA finalization and implementation of research centre and vendor audits, as assigned
- Develop a culture that improves quality;
- Any other responsibility as assigned.
- Development of a cross functional project plan according to the relevant company procedure
- Coordinate research centre readiness for the conduct of clinical trials
Job Specifications/Qualifications Candidates for this position should have the following education/experience and demonstrate mastery of the following knowledge, skills, and abilities:
- Bachelor’s degree in life science or healthcare field, or equivalent.
- Extensive experience in relevant clinical research.
- Good knowledge of regulatory and ICH/GCP guidelines required.
- Willingness and ability to travel as required.
- Ability to motivate and mentor, maintain positive interpersonal relationships.
- Familiarity with HIV/AIDS and/or Africa/Asia medical settings is desired.
- Creative, constructive, responsive approaches to multiple expected and unanticipated challenges of rigorous, large-scale, multi-center and multi-cultural clinical research trials, especially in developing country and in community-based settings.
- Highly motivated and team oriented, but also able to work independently, assessing priorities and competently handling a variety of activities with a high degree of accuracy in a deadline-driven environment.
- Ability and willingness to mentor and manage a team.
- High level of confidentiality and professionalism required.
- Flexible, adaptable, and tolerant of some ambiguity; eager to acquire new skills and knowledge; and capable of working well under pressure.
- Demonstrated poise and maturity in communicating with high-level executives.
- Excellent time management skills. Demonstrated ability to organize and prioritize multiple projects and tasks.
- Initiative - highly motivated and team oriented, but also able to work independently, assessing priorities and competently handling a variety of activities with a high degree of accuracy in a deadline-driven environment.
- Strong written and verbal communication skills; must be able to communicate effectively.
- Superior attention to detail – is thorough when performing work and conscientious about every aspect of work.
Ad Visible Until: 27 March 2018
Vacancy Type: Permanent