Study Delivery Manager (Global SDM) - Remote Based in US - Oncology

Do you want to watch clinical development change, or do you want to be the one to shape it?

Because we're hoping you're here for the latter.

Who are we?

We Are PRA.

We are 16,000+ employees strong, operating in more than 90 countries. We are committed to saving lives and we are constantly striving to be the best at what we do. Our impact is real and we see it every single day. We are getting live saving drugs into the hands those who need them most.

Who are you?

You are a forward thinker. You are an innovator that refuses to settle. You want to push the boundaries and change not just what it means to be a Study Delivery Manager, you want to change the future. You want to learn from the best, grow your knowledge and your skill set, and you want to build your career here. You want to use the latest technology and tools in the industry to push the momentum of an already growing company forward. You want to find a balance that still lets you be, well, you. Most of all, you want to do it in a place where you're more than an employee number. A place you love working.

Still here? Good. Because if this is you, we'd really like to meet you.

Qualifications

What do you need to have? Education:
  • Undergraduate degree preferred or its international equivalent preferably in clinical, science, or health-related field from an accredited institution; a licensed health-care professional, i.e., registered nurse
Required skills
  • 3+ years of clinical research experience required
  • 2+ years monitoring experience preferred
  • Read, write and speak fluent English; fluent in host country language required.
To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.

Responsibilities

What will you be doing? As a Study Delivery Manager, you will be pivotal to trial delivery and compound development for the global R&D organization, providing leadership and driving decisions related to the conduct of a clinical trial. The CSM leads and manages the operational implementation of country feasibility, planning and delivery of R&D Phase I-IV clinical studies within and across therapeutic areas. The CSM serves as the operational point-of-contact between the Central Study Team and in-country staff aligned to the study.
  • Works in an environment that is constantly evolving with new processes and systems, internally and externally and the CSM needs to be able to adapt to these changes quickly and efficiently. Flexible and resilient with ability to evolve in changing and challenging environment.
  • Excellent leadership skills, promoting motivation and empowerment of others in order to accomplish individual, team and organizational objectives.
  • Demonstrates an excellent understanding of the clinical study, drug development, sample management and other associated processes and quality requirements.
  • Strong project management mindset and demonstrated ability to work and lead in a matrix team environment involving both internal and external partners.
  • Able to represent 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 collaborate extensively with geographically distant central team members. Ability to work effectively in a remote environment.
  • Able to set and manage priorities and performance targets in a local environment.
  • Effectively plans, communicates, coordinates and facilitates delivery of team objectives.
  • Solid understanding of country local regulations, ICH-GCP guidelines and written standa
  • Available and willing to travel for project related activities as required (e.g. Investigator & Monitors Meeting attendance.
  • Acts as role model in line with core values and behaviors.
  • Able to understand the impact of technology on studies and to use/develop computer skills while making appropriate use of systems/software.
  • Demonstrates conceptual, analytical and strategic thinking.
  • Effective at problem solving and conflict resolution.
  • Demonstrates good English language written and verbal communication skills in addition to proven negotiation skills.
  • Flexible with high learning agility.
  • Strong computer skills
Accountable for high quality execution/delivery of studies within country as defined by the protocol & per agreed timelines / budget; overall project management of study activities.With limited oversight:
  • May provide input into the study concept, protocol, logistics and may co-ordinate other expert local input
  • Assess appropriateness of study for local environment.
  • Conducts country/site feasibility.
  • Leads selection of sites within country; accountable for site performance.
  • Ensures development and maintenance of country study plan and forecast, including budgets, resource estimates, milestones, timelines, quality, and risk planning.
  • Selects & manages local vendors in accordance with local practices & in alignment with overall resourcing strategy for the study; accountable for vendor management including oversight, agreements, payments, communications & issue management.
Accountable to manage recruitment into clinical studies in accordance to relevant country commitments including contingency planning.
  • Accountable for the creation and management of study budgets (budget updates, expenditures including site payments across a study) and reporting of accrual to finance department.
  • With oversight:
  • Manages the development of key study documents, plans & manuals according to local requirements (e.g., monitoring plan, local informed consent form, import/export licenses etc.); develops local recruitment and other site support materials.
  • Ensures development of country / site-level study risk assessment to proactively identify areas at risk, develop a mitigation plan and communicate to management and study teams locally and globally.
  • Responsible for submitting or assisting with (in accordance with local regulations and LOC standard practice) the ethics committee/IRB In some cases, may also be accountable for Regulatory Authority submissions and approvals.
  • Arranges accurate translations of key study documentation into local language as required.
  • Provides support / develops and negotiates Clinical Trial Agreements (depending on local practices) with the investigational sites, ensuring legal input where required.
  • Ensures necessary supplies are available at sites and manages local supply inventory.
  • Ensures in-country study oversight: coordinates local internal & external operational activities; maintains clear visibility to sites' progress and issues; reviews in-country protocol deviations; metrics; manages in-country study communications; ensures appropriate issue escalation & follow- through within country and above country; communicates status/issues effectively to central team; ensures monitoring plan is followed.
  • Build close working relationships with key partners including local medical staff.
  • 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.
  • Ensure the quality and integrity of clinical studies conducted in the LOC by taking on appropriate business management monitoring activities
  • 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.
  • Accountable 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.
  • Escalates resourcing issues to ensure that in-country study activities are appropriately resourced.
  • Ensures robust communication 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).
  • Ensures conduct of assigned studies in the country according to all applicable regulations, ICH/GCP and written standards.
  • Reviews, ensures completeness and maintains accuracy of Sponsor Study Records.
  • Co-ordinates / contributes to end of study / program learning debriefs and identify areas for improvement.
  • Acquires and maintains therapeutic area and product specific knowledge for the designated therapy area, study protocol training and all study related activities. Participate continuously in relevant training courses to improve personal/professional skills.
  • Keep up to date with all the changes / required knowledge on ICH GCP, written standards and attending appropriate training sessions.
  • Requirement to interact and collaborate with Country study staff
  • Requirement to 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


United States-Remote