Current Opportunities at Thermo Fisher Scientific

Discover Impactful Work:

• This position provides strategic leadership and tactical oversight for the clinical/medical aspects of all phases of the clinical drug development process. This person is responsible for the design, development and execution of Clinical Development Plans (CDPs), clinical trials and protocols in accordance with applicable GCP regulations. This person leads and contributes to the analysis of study results, the assessment of the extent to which the study(ies) has achieved clinical/regulatory objectives and the documentation of study results.
• This person may act as a clinical/medical representative in meetings with external stakeholders (e.g. collaborators, Key Opinion Leaders (KOLs), investigators, regulatory authorities, etc.), partners (e.g. vendors, consultants, etc.) and other external audiences as needed.

A day in the Life:

• Provides medical content and leadership of the clinical studies
• Medical Monitoring of clinical studies
• Establish and approve scientific methods underlying the design and implementation of clinical protocols
• Ensure study subject safety
• Regularly review adverse event, laboratory and other clinical data, ensure reporting is done on a timely basis
• Collaborate with the study executive and independent safety committee when needed
• Represent clinical research through membership on trial teams.
• Contributes to, reviews and approves study protocols, protocol amendments, study manuals, Investigator Brochures (IBs), Clinical Study Reports (CSRs), Informed Consent Forms (ICFs), Case Report Forms (CRFs) and other clinical documents as required for the conduct of clinical trials
• Interprets, summarizes and documents clinical data for regulatory documents (e.g. INDs, Annual Reports, NDAs, MAAs, etc.), manuscripts, and other publications as required.
• Collaborate with leading academic medical centers
• Recruit, guide and motivate clinical investigators
• Ensure study compliance by understanding and applying all relevant SOPs and GCPs
• Participate in long range strategic planning

Education

• MD degree with specialization in Psychiatry/ Neurology is mandatory
• Drug Development experience in the area of Psychiatry/ Neurology
• Desirable: Experience in the therapy areas of (Monoclonal Antibodies) and/or Translational Medicine.

Knowledge, Skills, Abilities

• Demonstration and commitment to vigilant proactive problem solving
• Excellent leadership abilities
• Able to provide multiple examples of creating and implementing the scientific and clinical principles used for the preparation of clinical studies and clinical trial protocols.
• Demonstrated expertise in clinical trial design, conduct and interpretation of clinical data.
• Previous experience with regulatory submissions.
• Excellent written and verbal communication skills.
• Ability to travel.

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Position Overview:

• Performs and coordinates different aspects of the clinical monitoring and site management process. Conducts remote or on-site visits to assess protocol and regulatory compliance and handles required documentation. Manages procedures and guidelines from different sponsors and/or monitoring environments (i.e. Government, FSO, FSP, etc.). Acts as a site processes specialist, ensuring that the trial is conducted according to the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects rights, well-being and data reliability. Ensures audit readiness. Develops collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to role are outlined in the task matrix.

Essential Duties and Responsibilities:

• Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assess investigational product through physical inventory and records review. Documents observations in reports and letters using approved business writing standards. Raises observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts monitoring tasks in accordance with the approved monitoring plan.
• Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.
• Provides trial status tracking and progress update reports to the team as required. Ensures study systems are complete, accurate and updated per agreed study conventions (e.g. Clinical Trial Management System).
• Facilitates effective communication between investigative sites, client company and internal project teams through written, oral and/or electronic contacts. Responds to company, client and applicable regulatory requirements/audits/inspections.
• Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follow-up on findings as applicable. Participates in investigator meetings as vital. May help to identify potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Performs trial close out and retrieval of trial materials.
• Maintains and completes administrative tasks such as expense reports and timesheets in an accurate and timely manner.
• Contributes to the project team by assisting in preparation of project publications/tools and sharing ideas/suggestions with team members.
• Contributes to other project work and initiatives for process improvement, as required.

Education:

• Bachelor's degree in a life sciences field.
• Clinical monitoring experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 2-3 yrs) in a clinical environment where experience is gained in clinical trials, medical terminology, medical research, clinical research or health care or experience in a health sciences field with formal training in medical terminology and anatomy may be considered.
• Valid driver's license where applicable.
• 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 & Abilities:

• Basic medical/therapeutic area knowledge and understanding of medical terminology.
• Ability to attain and maintain a proven understanding of ICH GCPs and industry regulations and procedural documents.
• Good oral and written communication skills, with ability to communicate effectively with medical personnel.
• Good interpersonal skills.
• Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers’ underlying issues.
• Good organizational and time management skills.
• Ability to remain flexible and adaptable in a wide range of scenarios.
• Well-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving.
• Ability to manage Risk Based Monitoring concepts and processes.
• Ability to work in a team or independently as required.
• Good digital literacy: proven knowledge of Microsoft Office and ability to learn appropriate software.
• Good English language and grammar skills.
• Flexibility to travel in-country and to other countries within Africa.