Senior Manager Clinical Operations

2 weeks ago

Pretoria, Gauteng, South Africa Thermo Fisher Scientific Full time

At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Our global Clinical Operations colleagues within our PPD clinical research services provide end-to-end support for clinical trials from study start up to monitoring through to study close out, across commercial and government contracts. Together, we help clients define and develop clinical programs, minimize delays, and execute high-quality, cost-efficient clinical studies.

We have an exciting opportunity for within our wonderful team in Türkiye

Summarized Purpose:

Manages, selects, trains, resources, coaches and performance management of respective staff, which may be inclusive of CAS, CS, CRAs,CTCs, ACRAsand/or other clinical operations focused staff. Focuses on end results using metrics and key performance indicators to manage performance. Leads or contributes to initiatives that enhance the department's performance or lead to process improvement across the company. Collaborates with clinical operations senior management and executive staff on strategic planning and business development. Acts as point-of-escalation regarding performance concerns and training needs to ensure adherence to the company's 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 leads/functional leads 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. Assures adherence to good ethical and regulatory standards. Alerts management to quality issues, request QA audits as appropriate, and facilitate client and internal quality assurance audits as required. Manages and reviews systems ( Activate, CTMS, Preclarus, Clarity) to evaluate employee and project metrics, KPIs and general project status. Evaluates work of staff, including conductingMAs(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. Provides input into bids and contribute to the procurement of new business where required. Assists senior management in budgeting activity of assigned group(s) and supports annual and long-range forecasting.

Qualifications:

Education and Experience:

Bachelor's degree or equivalent and relevant formal academic / vocational qualification Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years). 2+ years of management responsibility

Knowledge, Skills and Abilities:

Excellent mentoring/leadership/supervisory skills Excellent clinical trials monitoring skills; Remote and on-site Advanced knowledge of clinical trials monitoring; Remote and on-site Advanced understanding of or ability to learn the company's SOPs, WPDs, and relevant regulations ( ICH/GCP, FDA guidelines) Demonstrated ability to evaluate medical research data Advanced organizational and negotiation skills Strong attention to detail Excellent written and oral communication skills Good knowledge of English language and grammar Advanced 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 Excellent ability to utilize problem-solving techniques applicable to constantly changing environment Advanced knowledge of medical/therapeutic areas and medical terminology

What we offer:

At PPD clinical research services we hire the best, develop ourselves and each other, and recognize the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD clinical research services you will benefit from an, ensuring you reach your potential.

As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a, where PPD clinical research services truly value a work-life balance. We've grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organization but with a local feel.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

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