PPD (Senior) Country Study Manager, client-dedicated - UK in Middlesex, United Kingdom
Clinical Study Manager – Client-dedicated – UK
We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients.
Our team is expanding, and we are looking to recruit a CSM to be dedicated to one client only, using and working with their systems, SOPs and monitoring only studies.
_Responsibilities include but are not limited to:_
•The Country Study Manager (CSM) is 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.
•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.
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 Client’s LOC standard practice) the ethics committee/IRB submissions. 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 client’s 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.
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.
/Education and Experience:/
Degree in pharmacy, life science or related field
Study management experience
FSP experiencewould be ideal
Fluency in English
Experience in the UK
*/Knowledge, Skills and Abilities:/
Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
Excellent understanding and demonstrated application of GCPs and applicable SOPs
Management of regulatory and / or IEC questions
Development and preparation of the local informed consent form
Effective oral and written communication skills, with the ability to communicate effectively with medical personnel
Management of the delivery of study supplies
Strong customer focus
Effective interpersonal skills
Strong attention to detail
Effective organizational and time management skills
Proven flexibility and adaptability
Ability to work in a team or independently as required
Good computer skills: good knowledge of Microsoft Office and the ability to learn appropriate software
Good presentation skills
/What we offer:/
At PPD we hire the best, develop ourselves and each other, and recognise 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 you will benefit from an award-winning learning and development programme, 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 haveaflexible working culture, where PPD 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 aglobal organisation but with a local feel.
- We have a strong will to win - We earn our customer’s trust - We are gamechangers - We do the right thing -We are one PPD -
If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we’d love to hear from you.
Please note that due to the high volume of applications, only short-listed candidates will be contacted.
PPD is an equal employer.
Job: *Clinical Monitoring
Organization: *GB BU
Title: (Senior) Country Study Manager, client-dedicated - UK
Requisition ID: 184299
Other Locations: GB-GB-Bellshill, GB-GB-Cambridge, GB-GB-Stevenage, GB-GB-Middlesex, GB-GB-Winchester
PPD is an affirmative action employer that values diversity as a strength fosters and environment of mutual respect. PPD provides equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or other status within any other protected group