Work Schedule
Standard (Mon-Fri)


Environmental Conditions
Office


Job Description


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.


The PPD FSP Solution:

PPD's Functional Service Provider division partner with and serve as an extension of our PPD team, supporting our customers key functions. We cover customer needs on every level, allowing them to do more with less, with an uncompromising commitment to quality. We deploy the same top-tier talent in ALL engagement models. Exceptionally trained, rigorously supported and technologically empowered to help customers manage capacity and set programs up for success.


Joining within our PPD FSP functional area, allows you to join the renowned PPD CRO and still gain invaluable client dedicated experience.


## Discover Impactful Work:

Accountable for achieving the final clinical deliverable (usually clean data from evaluated patients as specified in the study protocol) within the time period specified in the contract with the customer. Interprets data on project issues and makes good business decisions with support from experienced team members or line manager. Works to ensure that all clinical deliverables meet the customer's time/quality/cost expectations. Maintains profitability by ensuring clinical activity is conducted within contract scope, through efficient management of the clinical team. Typically works on projects of low to moderate complexity and as part of a team of CTMs.


## A day in the Life:


- Leads the local study team consisting of within-country clinical operations team members, cross-functional experts (medical, regulatory, supply logistics, finance, legal, etc.), vendor staff, and external clinical site staff involved in study preparation and delivery providing both matrix leadership and project management of study activities within the country(ies).
- Serves as the operational point-of-contact between the central study team and within-country(ies) study team. The LDL collaborates closely with local medical and regulatory affairs staff to align local medical and scientific requirements. As required, collaborates with the local and above-country teams for conducting study feasibility and site selection within country(ies). Leads selection of sites within country(ies) and is accountable for local study performance.
- Accountable for within-country delivery of assigned studies to time, budget, and quality expectations as defined in the clinical development plan and study protocol as well as in local/regional regulations, IND/GCP/ICH-guidelines, and procedures. Ensures quality and integrity of clinical studies by taking on appropriate business management monitoring activities.
- Ensures development and maintenance of country study plan and that critical study timelines related to study activities within-country(ies) are accurately forecasted and achieved, including budgets, resource estimates, milestones, timelines, quality and risk planning, and that recruitment targets, patient recruitment cycle times, data, and audit/inspection quality are met. Provides troubleshooting and problem resolution support for within-country study team to ensure productive, efficient study delivery. Ensures necessary supplies are available at sites and manages local supply inventory.
- Accountable for the accuracy of study systems, including completeness of the trial master file, and reporting study delivery progress to study team and key stakeholders and to specify and review in-country study monitoring tracking tools, monitors key risk and performance indicators, and other reports. Review all study databases to ensure 100% accuracy.
- Ensures development of country/site-level risk assessment to proactively identify risks, develop a mitigation plan, and escalate issues and risks that may impact study delivery.
- Will review and approve monitoring visit reports and ensure appropriate site monitoring activities have been completed per the study monitoring plan.
- May provide feedback on performance, capabilities, and competencies of local study members to line management.
- Has the accountability to create and manage study budgets (budget updates, expenditures including site payments across a study) and estimate, track, and deliver against the local budget for the studies within their scope of responsibility. As required, advises support/develops and negotiates on contract development with Sites/CRO/Vendors ensuring legal input where required and may participate in budget/contract negotiations with study vendors or clinical investigator sites. As required, selects & manages local vendors in accordance with local practices & in alignment with overall resourcing strategy for the study; accountable for local vendor management including oversight, agreements, payments, communications & issue management.
- Manages the development of key study documents, plans & manuals according to local requirements (monitoring plan, local informed consent form, import/export licenses, etc.). May provide input into the study concept, protocol, logistics, and may coordinate other expert local input. As required, may arrange accurate translations of key study documentation into the local language.
- As required, prepares the local Informed Consent Form and coordinates the submission of the Clinical Study Application to Regulatory Authority (RA) and local Ethics Committees (ECs). Maintains communication with RA and ECs to ensure all regulatory requirements are met in a timely manner throughout the study. May also be accountable for Regulatory Authority submissions and approvals.
- Acquires and maintains an appropriate level of knowledge on the study compound, protocol, pathology of the disease area being studied, competitive landscape within country(ies), local treatment/immunization guidelines, and local health care system requirements, as well as study protocol training and all study-related activities. Participate continuously in relevant training courses to improve personal/professional skills.
- As required, assists with audits/inspections of local clinical operations department and study/sites in the country(ies). May act as a point of contact for regulatory/compliance audits of assigned study(s); provides input into LOC and site assessment/audit proposals and delivers country response & follow-up to assessment/audit reports.
- Continuously develops and keeps up-to-date knowledge in the areas of GCP, internal company guidelines, SOPs, new monitoring, site, and project management skills and capabilities. Responsible to identify and share standard processes.
- Open to travel as needed for the role.
- Ensures appropriate training of in-country staff and investigator sites; coordinates & delivers operational aspects at local study meetings including investigator meetings, monitor meetings, and local training.
- Escalates resourcing issues to ensure that in-country study activities are appropriately resourced.
- Ensures robust communication and engagement with sites, e.g., timely communication of protocol amendments.
- Reviews and approves Monitoring Visit Reports (MVRs) for their study(s) within agreed timelines to obtain an understanding of current site status.
- Ensures ongoing management and reporting of study-specific safety issues and safety report handling, as required (including SAE reporting).
- Coordinates/contributes to end-of-study/program learning debriefs and identifies areas for improvement.
- Interact and collaborate with country study staff and staff from other functions as needed (e.g., Medical, legal, finance, etc.).
- Communicate and work effectively with medical staff/(...)

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