Jobs Kenya

Company Address: Address 929 North Front Street Wilmington, NC 28401-3331

  • Experienced Clinical Team Manager – Vaccines or Infectious Diseases

    Experienced Clinical Team Manager – Vaccines or Infectious Diseases

    Requisition ID: 162755
    This exciting and unique role could take you to the next step of your career within Clinical Research. The role coordinates all aspects of clinical activities on an international basis. This includes the day to day management and leadership of a team of Clinical Management members who are allocated to a project on a Country basis. You will work in partnership with the Project Manager to ensure the necessary training, tracking and quality systems are in place for the clinical team, and be primarily responsible for the clinical deliverables of the Project within agreed timelines and budget. Clinical Team Managers provide contact and support to the project sponsor for all clinical aspects.

    We are seeking high performing individuals who enjoy a fast-paced environment and have had Clinical Project Management experience and exposure to international studies. You need to have exceptional interpersonal and problem-solving skills, with the ability to lead CRAs in different countries.

    Sounds like you? We are offering a role in a matrix environment with opportunities to mentor and integrate international teams and develop your career.
    If you are highly motivated and skilled professional who wants to be part of our continued growth at the international market place, this is your opportunity.

    Must Have

    Bachelor’s degree or licensed certified health care training or equivalent combination of education and experience
    Previous cross-country CTM/ Project Management experience in excess of 2 year, including specific knowledge for some of the below therapeutic areas:

    IRD/Vaccines: Pneumococcal, dengue, shigella, Ebola, TB, chikungunya, Eosinophilic asthma, Rare Disease respiratory (idiopathic pulmonary fibrosis, pulmonary hypertension)

    Gene therapy experience would be considered as an advantage
    Clinical research experience in all phases of study life cycle, including start up, interim and close out
    Study finance management experience
    Ability and willingness to cross-region and in region travel according to the project needs
    Be competent in use of written and oral English language

    Knowledge, Skills And Abilities

    Superior organizational skills
    Strategic thinking skills
    Demonstrated performance management abilities
    Excellent judgment and decision-making skills
    Highly effective verbal and written communication and presentation skills
    Expert knowledge of relevant regulations e.g. ICH/GCP, FDA guidelines, etc.

  • Principal QA Auditor

    Principal QA Auditor

    Job description
    We have an exciting career opportunity within our Global Quality and Compliance department:

    This role will primarily be in support of the GCP audit program but will include opportunities to participate in audits associated with the PV audit program.

    The Major Responsibilities The Principal QA Auditor Will Include

    Conducting complex internal and external audits and inspections to ensure compliance with established quality assurance processes, standards, global regulatory guidelines and/or client contractual obligations.
    Identifying issues impacting the quality and/or integrity of clinical research programs, determines root cause of non-conformance and develops strategies to address issues.
    Performing technical document review and other GxP practice activities in support of clinical development programs.
    Providing audit reports to management.
    Serving in a lead capacity providing mentorship and guidance to junior auditors. Facilitates client audits or regulatory authority inspections.
     

    Education And Experience
     

    Bachelor’s degree or equivalent and relevant formal academic / vocational qualification
    Previous QA experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years’) or equivalent combination of education, training, and experience.
     

    Knowledge, Skills And Abilities
     

    Expertise in GxP and appropriate regional clinical research regulations and guidelines
    Excellent training/mentoring experience of junior auditors on a variety of co-audit types
    Solid experience with a wide range of GxP audits (e.g. routine, directed, vendor, internal, database, client audits, complex process and systems audits)
    Excellent oral and written communication skills
    Well developed problem solving, risk assessment and impact analysis abilities
    Extensive experience in root cause analysis
    Strong negotiation and conflict management skills
    Flexible and able to multi-task and prioritize competing demands/work load
    Valid driver’s license and ability to qualify for and maintain a corporate credit card with sufficient credit line for business travel

    We Will

    Provide initial training
    Ensure a working environment of high quality and standards
    Offer a competitive remuneration package
    Give you an opportunity for a challenging and rewarding career
     

    In order to apply, please submit your CV in English. PPD is an equal opportunities employer.

    Additional Information
     

    Requisition ID: 159274

  • Senior Clinical Research Associate: Kenya

    Senior Clinical Research Associate: Kenya

    Requisition ID: 154480
    The Senior Clinical Research Associate (CRA) performs and coordinates all aspects of the clinical monitoring and site management process in accordance with ICH Good Clinical Practices, FDA guidelines, local regulations and PPD Standard Operating Procedures.
    Key Responsibilities Include

    Conducts site visits to assess protocol and regulatory compliance and manages required documentation
    Responsible for ensuring that data will pass international quality assurance audits.
    Represents PPD in the global medical research community and develops and maintains collaborative relationships with investigation sites and client company personnel.
    May assist project manager or clinical team manager on assigned projects.
    Travel across Africa, but in particular Kenya, Tanzania, Uganda & Ethiopia

    Education And Experience

    Bachelor’s degree in a science related field or a Registered Nursing certification or equivalent certification/licensure from an appropriately accredited institution
    Previous experience as a clinical research monitor (comparable to 3+ years) that provides the required knowledge, skills and abilities
    Valid Driver’s License where applicable
    In some cases an equivalent combination of education, professional training, and experience that provides the required knowledge, skills and abilities may be considered

    Knowledge, Skills and Abilities:

    Effective clinical monitoring skills
    Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
    Excellent understanding and demonstrated application of Good Clinical Practices and applicable Standard Operating Procedures
    Effective oral and written communication skills, with the ability to communicate effectively with medical personnel
    Strong customer focus
    Effective interpersonal skills
    Strong attention to detail
    Effective organizational and time management skills
    Proven flexibility and adaptability
    Ability to work in a team or independently as required
    Good computer skills: good knowledge of Microsoft Office

    Pharmaceutical Product Development, LLC is firmly committed to Equal Employment Opportunity (EEO) and prohibits employment discrimination for employees and applicants based on age, race, color, pregnancy, gender, gender identity, sexual orientation, national origin, religion, marital status, citizenship, disability or protected veteran or other status protected by federal, state, and/or local law.