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  • Posted: Apr 22, 2021
    Deadline: Not specified
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    PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 47 countries and more than 19,000 professionals worldwide, PPD applie...
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    Dir Clinical Mgmt

    Provides strategic direction, leadership and management within an area of a region to secure the successful completion of clinical deliverables within assigned studies. This includes training and management of staff to contribute to the successful delivery of clean data from evaluable patients within project parameters of time, quality, and cost. Provides direct supervision, support, training and mentoring to their staff regarding all general aspects of the CTM and Clinical Manager roles. Will be responsible for performance assessments and annual review of their direct reports.Assists in resource utilization, policy development and implementation of goals by working with leadership in all functional areas on the continuous development of business processes to support cross functional teams ensuring work is uniform, complete and managed appropriately within assigned functional area. In developing regions, responsibilities may include oversight of all deliverables within a country/region including participation in business development activities.

    Essential Functions

    • Supervises and coordinates Clinical Management functions, including mentoring managers in day-to-day activities and responsibilities related to the clinical deliverables. Ensures the clinical teams are provided with the necessary support and resources to successfully deliver clinical deliverables, e.g., oversees study start-up, monitoring and site management deliverables. At a country level, may liaise with other functional departments to ensure delivery of projects to clients and contribute to feasibility projects
    • Ensures the timely execution of clinical deliverables with a focus on quality deliverables. In those cases, develops and drives the specific and overall project or program strategies to ensure optimum performance and achievement of annual plans and targets. Facilitates meetings to identify potential risks and work with the clinical team to develop and communicate contingency plans. Ensures risks to clinical deliverables and potential solutions are communicated through appropriate escalation pathways. Reviews and assesses clinical project or program finances and ensures risks are escalated appropriately with any information necessary for a contract modification
    • Manages clinical management resource levels including hiring and promoting, as appropriate. Participates in resource calls and ensure teams are provided with adequate levels of appropriately qualified resources
    • Inducts new managers to PPD. Provides performance appraisals, evaluate and allocate bonuses and merit increases, as appropriate. Develops and motivates through goal setting, ongoing feedback, formal evaluation, and effective delegation of decision making. Ensures staff is trained and mentored according to company policies and procedures. Develops, implements and reviews key performance metrics
    • Manages the overall budgeting activity of the assigned group(s) - annual and long range forecast
    • Participates in global and/or cross-functional initiatives and process improvement projects

    Job Qualification

    • Bachelor's Degree in a science related field or equivalent combination of education, training, and experience that provides the individual with the required knowledge, skills, and abilities. In some cases, an equivalent combination of education, professional training and experience that provides the required knowledge, skills and abilities may be considered.
    • Significant clinical research experience (comparable to 12+ years) including remote and clinical monitoring and experience in all phases of study life cycle, including start up, interim and close out.
    • Line management experience appropriate to the size and complexity of the clinical management group in the designated country/region. Valid Driver's License and Passport.
    • Years of experience refers to typical years of related experience needed to gain the required knowledge, skills, and abilities necessary to perform the essential functions of the job. Years of experience are not to be used as the only determining factor in establishing the job class or making employment selection decisions.


    Knowledge, Skills And Abilities

    • Advanced leadership and management skills
    • Excellent judgment and decision-making skills
    • Excellent interpersonal and problem-solving ability
    • Expertise in negotiating and strong organizational skills
    • Excellent oral/presentation and written communication skills in the native language and in English
    • Ability to perform tasks required of a functional staff
    • Ability to successfully network with other Divisions (departments) where necessary
    • Strong knowledge of budgeting, forecasting and fiscal management
    • Demonstrated expertise in leading, motivating and integrating project teams
    • Self-motivated and possess good interpersonal skills and projects a positive attitude
    • Ability to effectively teach required skills
    • Excellent coaching and mentoring skills
    • Knowledge and understanding of clinical development regulatory guidelines and Directives
    • Ability to work effectively in a matrix organization

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    Clinical Research Associate - Customer-dedicated, Johannesburg

    The Clinical Research Associate (CRA) performs and coordinates all aspects of the clinical monitoring and site management process in accordance with ICH GCP, FDA guidelines, local regulations and Sponsor’s SOPs. The CRA conducts site visits to assess protocol and regulatory compliance and manages required documentation and ensures that data will pass international quality assurance audits. They also develop collaborative relationships with investigational sites.

    Job Qualification

    Education And Experience

    • Medical, pharmaceutical or other life-science related degree
    • At least 1 year of independent monitoring experience in a CRO, pharmaceutical or biotech company

    Additional Requirements

    • Demonstrated clinical trial monitoring skills
    • In-depth understanding of ICH/GCP guidelines
    • Excellent standard of verbal and written communication skills in English
    • Highly organized with strong attention to detail and deadlines
    • Advanced skills across all of the Microsoft packages
    • Willingness to travel in South Africa and Africa

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    Country Approval Specialist (Clinical Trial submissions)

    PPD is currently looking for a Country Approval Specialist to join our team in South Africa ideally working form the office in Johannesburg although flexibility may be offered to experienced candidates .

    • Prepare, review and coordinate, under guidance, local regulatory submissions ( MoH , EC, additional special national local applications if applicable, e.g. gene therapy approvals, viral safety dossiers, import license) in alignment with global submission strategy
    • Provide, under guidance local regulatory strategy advice ( MoH &/or EC) to internal clients
    • Provide project specific local SIA services and coordination of these projects
    • May have contact with investigators for submission related activitie s
    • Key-contact at country level for either Ethical or Regulatory submission-related activities
    • Coordinate, under guidance, with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensures alignment of submission process for sites and study are aligned to the critical path for site activation
    • May work with the start-up CRA(s) to prepare the regulatory compliance review packages, as applicable
    • May develop country specific Patient Information Sheet/Informed Consent form documents
    • May assist with grant budgets(s) and payment schedules negotiations with sites.
    • Support the coordination of feasibility activities, as required, in accordance with agreed timelines
    • Enter and maintain trial status information relating to SIA activities onto PPD tracking databases in an accurate and timely manner
    • Ensure the local country study files and filing processes are prepared, set up and maintained as per PPD WPDs or applicable client SOPs
    • Maintain knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provide

    Job Qualification
    Requirements    
    To be considered for the role of Country Approval Specialist you should have:

    • Bachelor's degree
    • 2 years related experience or equivalent combination of education, training, & experience
    • Effective oral and written communication skills
    • Excellent interpersonal skills
    • Strong attention to detail and quality of documentation
    • Good negotiation skills
    • Good computer skills and the ability to learn appropriate software
    • Excellent English language skills
    • Basic medical/therapeutic area and medical terminology knowledge
    • Ability to work in a team environment or independently, under direction, as required
    • Basic organizational and planning skill s
    • Basic knowledge of all applicable regional / national country regulatory guidelines and EC regulation

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    (Senior) Clinical Team Manager - Hemathology/Oncology (preferably Immunotherapies or phase I)

    Does this sound like you? If so, you need to 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 Hemathology/Oncology: Ovarian cancer, Immunotherapies or phase I
    • 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.

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    (Senior) Clinical Research Associates - South Africa - Home Based with 100,000 ZAR joining bonus!

    As a Clinical Research Associate, You Will

    • Thrive in multi-national project teams and be focused on delivering exemplary levels of customer service on multiple, challenging projects.
    • Have excellent communication and interpersonal skills and are looking to work in a collegiate environment where you want to take true ownership for your work.
    • Perform and coordinate all aspects of the clinical monitoring process.
    • You shall also be qualified to conduct monitoring activities independently.
    • Benefit from award winning training programmes that will assist your technical and professional skills and knowledge

    Job Qualification
    Qualifications
    Education and Experience:

    • University degree in a life-sciences field
    • Minimum 1+ year of I ndependent, on-site monitoring experience in a Pharmaceutical or Clinical Research Organisation
    • Demonstrated understanding of ICH-GCP, EU and FDA requirements
    • Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
    • Exceptional communication, collaboration, organi s ational and time management skills
    • Fluency in English language is essential

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    (Senior) Clinical Team Manager - Government and Public Health Services

    Works to ensure that all clinical deliverables meet the customer's time/quality/cost expectations. Maintains profitability by ensuring clinical activity is conducted within contract scope, through efficient management of the clinical team. In smaller regions, may be responsible for coordinating all project activities (regulatory, etc.) and be accountable for project financials. Also responsible for line management, selection, training, coaching and performance management of clinical personnel assigned to their team.

    Job Qualification
    Education And Experience

    • Bachelor's degree or licensed certified health care training
    • Significant clinical research experience (comparable to 3 years) in all phases of study life cycle, including start up, interim and close out
    • Valid Driver's License
    • Valid Passport

    Knowledge, Skills And Abilities

    • Superior organizational skills
    • Demonstrated performance management abilities
    • Extensive unblinded monitoring experience
    • Excellent judgment and decision making skills
    • Effective oral and written communication skills
    • Excellent interpersonal skills and problem solving ability
    • Ability to motivate and integrate teams and teach/mentor team members
    • Able to effectively prioritize workload
    • Strong attention to detail
    • Expert knowledge of relevant regulations e.g. ICH/GCP, FDA guidelines, etc.
    • Computer skills
    • Able to communicate in English, both orally and in writing
    • Ability to travel

    Method of Application

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