Thermo Fisher Scientific Hiring BSc Life Sciences For Clinical Ops Position

Thermo Fisher Scientific Clinical Ops Job For BSc Life Sciences

Thermo Fisher Scientific Clinical Ops Job For BSc Life Sciences. Thermo Fisher Scientific Inc. is an American supplier of analytical instruments, life sciences solutions, speciality diagnostics, laboratory, pharmaceutical and biotechnology services. Thermo Fisher Scientific Hiring Clinical Operations Manager. Interested candidates check out the details below and Apply online

Job title: Manager Clinical Operations

Job Location: Mumbai, India

Job ID: 230186

Job Category: Clinical Operations

Job Type: Full Time

Job Description :

Summarized Purpose:

Manages, selects, trains, resources, coaches and performance management of respective staff, which may be inclusive of CRAs, PAs, RSMs and other clinical focused staff. Focuses on end results using metrics and key performance indicators to manage performance. May lead or contribute to initiatives that enhance the department’s performance or lead to process improvement across PPD. Collaborates with clinical operations senior management and executive staff on strategic planning and business development as required. Acts as point-of-escalation regarding performance concerns and training needs to ensure adherence to PPD SOPs and WPDs. Works in collaboration with the leadership team for resourcing needs.

Essential Functions:

• Manages staff, providing coaching, mentorship and work direction
• Conducts regular performance appraisals and career discussions with staff. Facilitates employee career development. Interviews, recruits and selects staff
• Manages and conducts induction/orientation programs for all new employees, ensuring their smooth assimilation into the company
• Ensures all staff CVs, training records, position profiles and experience profiles are complete and up-to-date. Ensures timeliness and accuracy of timesheets and expense reports
• Supports allocation activities per the local resourcing process. Supports activities of project managers and clinical team managers to optimize the operational running of projects. Escalates appropriately any issues which may impact project deliverables
• Delivers training on Working Practice Documents (WPDs) and Standard Operating Procedures (SOPs), local requirements and any other subjects that impact on clinical operations. Identifies training gaps and ensures that training requirements are met. May contribute to development of training programs, where appropriate
• Alerts management to quality issues, request QA audits as appropriate, and facilitate client and internal quality assurance audits as required
• Manages and reviews systems (e.g. CTMS, Preclarus, Clarity) to evaluate employee and project metrics, KPIs and general project status.
• Evaluates work of staff, including conducting PAVs (either remote or on-site) to thoroughly evaluate the employee monitoring skills and project conduction when applicable.
• Participates in process improvement/development initiatives.
• Ensures understanding and facilitation of the risk based monitoring approach.
• May provide input into bids and contribute to the procurement of new business where required.

Education and Experience:

• Bachelor’s Degree in a life science related field.
• Significant clinical research experience (comparable to 5+ 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.
• 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 and Abilities:

• Excellent mentoring/leadership/supervisory skills
• Advanced knowledge of clinical trials monitoring; Remote and on-site
• Demonstrated understanding of or ability to learn PPD SOPs, WPDs, and relevant regulations (e.g. ICH/GCP, FDA guidelines)
• Demonstrated ability to evaluate medical research data
• Strong organizational and negotiation skills
• Strong attention to detail
• Effective written and oral communication skills
• Good knowledge of English language and grammar
• Competent use of computer to include data entry, archival and retrieval
• Ability to travel as needed
• Excellent team player with team building skills
• Excellent interpersonal and conflict resolution skills
• Ability to utilize problem-solving techniques applicable to constantly changing environment
• Solid knowledge of medical/therapeutic areas and medical terminology

Working Environment:

PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive.

Below is listed the working environment/requirements for this role:

• Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
• Able to work upright and stationary for typical working hours.
• Able to work in non-traditional work environments.
• Able to use and learn standard office equipment and technology with proficiency.
• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
• May have exposure to potentially hazardous elements typically found in healthcare or laboratory environments.
• This role requires independent travel up to 40%, inclusive of traveling in automobiles, airplanes, and trains.

APPLY ONLINE

Thermo Fisher Scientific Hiring BSc life Sciences for Clinical Operations Manager Position. Here are five interview questions along with their potential answers:

Question 1: Can you discuss your experience in managing and leading clinical operations teams, and how you have ensured the success of projects within the clinical trial life cycle? Answer: Of course. In my previous role as a Clinical Operations Manager, I led a team of clinical research professionals, including CRAs and PAs, to ensure the successful execution of clinical trials. I provided coaching and mentorship to enhance their skills, conducted regular performance appraisals, and identified training needs. By closely monitoring key performance indicators and metrics, I managed team performance effectively. For instance, during a complex Phase III trial, I collaborated with the project management team to allocate resources optimally, resulting in streamlined operations and on-time deliverables.

Question 2: Could you provide an example of how you’ve implemented process improvements or contributed to the development of training programs within clinical operations? Answer: Certainly. In a previous project, I noticed inefficiencies in the onboarding process for new team members. I took the initiative to develop an improved induction program that included comprehensive training on our Working Practice Documents (WPDs) and Standard Operating Procedures (SOPs). This program not only ensured smooth assimilation of new employees but also contributed to enhanced adherence to quality standards. As a result, the training gap was minimized, and the team’s overall performance improved.

Question 3: How have you handled challenging situations where project deliverables were at risk due to unforeseen issues? Can you share an example? Answer: Certainly. In a recent project, we encountered unexpected delays in site activation due to regulatory hurdles. This posed a significant risk to the overall timeline. To address this, I proactively engaged with both our internal team and the regulatory authorities to expedite the approval process. I collaborated with the project manager to reallocate resources to areas that were less affected by the delay. By managing priorities and leveraging our team’s strengths, we were able to mitigate the impact on the project timeline and successfully meet our goals.

Question 4: How do you ensure compliance with relevant regulations and quality standards within clinical operations? Can you provide an instance where your attention to detail made a difference? Answer: Compliance is a top priority for me. In a particular project, our team was audited by a client’s quality assurance team. I had meticulously ensured that all staff CVs, training records, and experience profiles were up-to-date and accurate. During the audit, these documents were readily available and in compliance with regulatory requirements, showcasing our commitment to quality. This level of preparation not only facilitated the audit process but also demonstrated our dedication to maintaining the highest standards.

Question 5: Can you share your approach to managing a diverse team of clinical research professionals? How do you foster teamwork and handle conflict resolution? Answer: Building a cohesive team is crucial. I emphasize open communication and encourage each team member to contribute their insights. Regular team meetings provide a platform for sharing experiences and discussing challenges, which promotes collaboration. In terms of conflict resolution, I believe in addressing issues promptly and privately. I encourage individuals to express their concerns and work together to find constructive solutions. By promoting transparency, mutual respect, and a shared sense of purpose, I’ve been able to create a positive and productive team environment.

Please note that these answers are provided as examples and should be tailored to your own experiences and style during an actual interview.

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