Job Openings at Thermo Fisher Scientific

Job Profile:

• 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. You will be fully integrated into the client's systems, using their SOPs.

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

go to method of application »

The Project Management, Early Development team are expanding and looking for an Associate Director to join them. As a leader in this team, you will be responsible for;

• Works effectively across multiple divisions to direct the delivery of projects within cost, time and quality requirements.
• Works with leadership in all functional areas on the continuous development/improvement of business processes to support cross functional teams and to ensure that work is uniform, complete and managed appropriately.
• Serves as a liaison with Business Development and Bids/Contracts for the client presentations and proposal development.
• Assists in resource utilization, policy development, and implementation of goals.
• This position may be responsible for directing and leading the activities of a therapeutic area within a Region and accountable for the P&L of a specific therapeutic area.
• Develops and drives the specific and overall therapeutic area strategies to ensure optimum performance and achievement of annual plans and targets.
• Has overall responsibility for instigating and leading change initiatives within the therapeutic area and works with peers of Therapeutic areas in the overall leadership of the Project Management group.

Keys to Success:

• Ensures the timely execution of clinical trials with a focus on quality deliverables for a segment of the business which may include an entire therapeutic group within a region. In those cases, develops and drives the specific and overall Therapeutic Area Strategies to ensure optimum performance and achievement of annual plans and targets. Facilitates hand-off meetings and kick-off meetings to identify potential risks and work with the project team to develop and communicate contingency plans. Ensures project risks and potential contingencies impacting time/quality/cost of deliverables are discussed with Senior Management through appropriate escalation pathways. Reviews and assesses project profitability through the identification of “out of scope” activity in a timely manner and supporting follow through on all aspects of contract modification.
• Manages the overall budgeting activity of the groups - annual and long range forecast.
• Accountable for the line management of project managers and senior project managers. Effectively recruits, inducts and retains staff. Provides ongoing coaching, feedback and training, addresses performance issues, responsible for formal performance appraisals, development plans and career coaching. Responsible for proposing salary and bonus recommendations and supporting recommendations with appropriate documentation.
• Communicates with sponsor(s) regularly to obtain direction and feedback on implementing scope of work as well as performance to date. Identifies unusual or significant problems encountered during the course of a clinical trial and proposes strategies for preventing or correcting significant problems.
• Assists in business development activities to obtain additional contracts by writing and reviewing proposals, making presentations to potential clients and representing the location/division at appropriate professional meetings and conferences. Fosters client relationships and supervise strategic sell initiative of the division.

Qualifications

• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 10+ years) or equivalent and relevant combination of education, training, & experience.
• 5+ years of management responsibility
• Proven leadership skills
• 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, Abilities

• Demonstrates strong leadership skills.
• Strong financial acumen.
• Excellent judgment and decision making skills.
• Effective oral and written communication skills including the ability to communicate in English, both orally and in writing.
• Excellent interpersonal skills and problem solving ability.
• Effective organization and negotiation skills.
• Expert knowledge of project management principles and application.
• Possesses depth of knowledge and practical application of budgeting, forecasting and resource management.
• A relationship builder who is able to work effectively in matrix organizations.
• Has successfully led national/international cross functional teams.
• Demonstrates cultural awareness and adapts appropriately.
• Knowledge of regulatory guidelines and Directives.
• Skilled in process improvement, especially as it applies to clinical trials, clinical development and project management.
• Knowledge of medical therapeutic area and medical terminology.
• Strong marketing and negotiation skills.
• Computer skills

Management Role:

• Directs through lower management levels and / or highly skilled specialist employees who exercise significant latitude and independent judgment.
• Often heads one or more departments or a large centralized staff function.
• In some instances may be responsible for a functional area (as determined by executive management) and not have subordinate supervisors or employees.
• May manage employees across multiple regions.