Manager Clinical Operations

PPD mission is enabling our customers to make the world healthier, cleaner and safer. It starts as an idea to find a cure. It becomes a life saved. All in-between, it’s you We know that meaningful results not only require the right approach, but also the right people. We invite you to re-imagine health promoting protocols with us, working alongside our talented, bright and energetic teams.
Our global Clinical department consists of colleagues with institutional knowledge, in-depth therapeutic experience, and robust operational tools. Together, we help clients define and develop clinical programs, minimize delays and execute high-quality, cost-efficient clinical studies.
As a people manager at PPD, you will oversee daily line management responsibilities of an assigned team and serve as positive leadership and professional role model for respective staff.
At PPD, part of Thermo Fisher, we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees.
**Summarized Purpose**:
Manages, selects, trains, resources, coaches and performance management of respective staff, which may be inclusive of CRAs, Clinical Trial Coordinators (CTCs), Associate CRAs (ACRAs) and Start Start Up staff, in full service or outsourcing model. 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. 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
- 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 Performance Assessment Visits (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, including at least 5 years of monitoring experience.
- Ideally, experience with all types of visits: PSVs, SIVs, IMVs and COVs
- Desirable line management experience appropriate to the size and complexity of the clinical management group in the designated country/region.
- Experience in a leadership role
- 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, 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
- Fluent in English: writing, reading, listening and speaking
- Spanish: desirable
- 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 knowledg

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