Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Job related skills

- Demonstrates flexibility and resilience with the ability to evolve in an always changing and challenging (internal and external) environment, processes, and systems.

- Demonstrates excellent leadership skills, promoting motivation and high-quality performance of others to accomplish individual, team and organizational objectives.

- Demonstrates an excellent understanding of clinical study, drug development, sample management and other associated processes and quality requirements. - Has a strong project management mindset and demonstrated ability to work and lead in a matrix team environment involving both internal (client) and external partners.

- Able to represent client to external physician investigators and other external clinical site staff, institutional review boards, etc., including the ability to answer complex questions.

- Able to work effectively within the local environment and if required other regional environments and collaborate extensively with remote central team members.

Ability to work effectively in a remote environment.

- Able to set and manage priorities and performance targets in a local environment and if required other regional environments.

- Effectively plans, communicates, coordinates, and facilitates delivery of local/regional team objectives.

- Demonstrates a solid understanding of country local regulations and if required basic understanding of other countries regulations, ICH-GCP guidelines and client written standards.

- Available and willing to travel for project related activities as required (e.g., Investigator & Monitors Meeting attendance).

- Acts as role model in line with client culture, including values and behaviors.

- Able to understand and apply new digital innovations to our clinical trials.

- Able to demonstrate conceptual, analytical and strategic thinking including data literacy.

- Effective at problem solving and conflict resolution.

- Demonstrates good English language written and verbal communication skills in addition to proven negotiation skills.

- Demonstrates flexibility with high learning agility.

- Demonstrates strong computer skills and the ability and willingness to learn and master new or evolving computer systems to support business requirements effectively.

Job Responsibilities

Leads the local study team consisting of within-country clinical operations team members, crossfunctional 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 client 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, client procedures.

Ensures quality and integrity of clinical studies by taking on appropriate business management monitoring activities.

Ensures development 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 incountry 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 to 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 co-ordinate other expert local input.

As required, may arrange accurate translations of key study documentation into 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 disease area being studied, competitive landscape within country(ies), local treatment/immunization guidelines and local health care system requirement, 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 & followup 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 best practices.

Available and willing to travel as job requires.

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).

Co-ordinates / contributes to end of study / program learning debriefs and identify areas for improvement.

Interact and collaborate with client Country study staff and staff from other functions as needed (e.g., Medical, legal, finance etc.)

Communicate and work effectively with medical staff/physicians/scientists who are often senior within their field, being mindful of their standing within the medical and/or research community.

Interactions with key partners including ethics boards, pharmacies, vendors.

Oversight LDL Job responsibilities

The oversight LDL conducts country level oversight in assigned Auxiliary& Other (A&O) countries.

The oversight LDL serves as the point-of-contact in the client Parent country and conducts oversight in regard to performance and delivery by the CRO for the assigned country.

Responsible for management of the performance and delivery of the CRO at country level.Consults and supports regarding country level risk identification and resolution. Consults and support during feasibility phase and responsible for final selection of sites.Consults and support with local vendor selection.Responsible for safety management plan completion for assigned A&O country. Consults during country level budget and contracting.Acts as the point of contact for issues and risk escalations at Parent country level.