PPD

CTM, Client-dedicated, UK

Company
PPD
Location
Cambridge, United Kingdom
Salary
Competitive
Posted
07 Jan 2021
Closes
06 Feb 2021
Ref
1178463
Discipline
Clinical Research
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
Clinical Team Manager, UK - client-dedicated

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.  

As a Clinical Team Manager (CTM), you combine deep knowledge, therapeutic expertise, and robust tools to help our clients deliver life-changing therapies to market. You take ownership, anticipate problems, find solutions and deliver results. The FSP CTM position offers a client dedicated opportunity to sponsor with our partners directly.

Responsibilities include:

- Lead the cross functional study Conduct team, Lead the Operational study lead

- Single point of accountability for overall execution of the study(ies)

- Mentor/oversee SDMs, study team member activities

- Oversight and driving of functional groups, such as Clinical Development, Global Regulatory Affairs, Clinical Pharmacology, Statistics, Medical Affairs, Data Management, Study Monitoring/LOCs and pre-Clinical Development

- Lead the writing of protocol related documents such as protocols, amendments, informed Consent Forms, etc (note: protocol writing and amendment may be performed in coordination with other functional team members and/or by scientist)

- Lead Study conduct team meetings (cross-functional team meeting, study country calls, study conduct team meeting, etc)

- Contribute to governance preparation - often times multiple scenario plans required (full timelines & budgets for each scenario).

- Coordination of operational feasibility of study protocol

- Development of preliminary study budget estimation (including review and validation of cross-functional budget additions)

- Review of study spend against overall budget

- Study delivery strategy (e.g. country selection, diversity, patient engagement strategy, vendor selection, submission strategy, training strategy, communication strategy etc.)

- Selection and management of vendors for outsourced clinical activities

- Study level operational risk management plan, ensuring local risk registers are complete and filed

- Study level plan development and management (Study Delivery Plan, Oversight Plans (study, country, vendor and eTMF), Slot allocation plan, Communication plan, Monitoring plan, Study training plan, SDV/SDV schematics , etc.)

- Oversight of delivery quality—escalation and resolution of performance issues (CRO/ vendors/ site/ country)

- Accountable for oversight of vendor activities, including performance, budget oversight, and contracting

- Delivery of study to plan (time, quality and budget)

Qualifications:

Requirements:

  • Life science degree
  • Strong Lead CRA and CTM experience
  • Experience in a client-dedicated role
  • Fluency in English


Knowledge, Skills and Abilities:

  • Strong leadership skills, effective at mentoring and training, and capable of motivating and integrating teams
  • Strong planning and organizational skills to enable effective prioritization of workload and workload of team members
  • Strong interpersonal and problem-solving skills to enable working in a multicultural matrix organization
  • Solid understanding of change management principles
  • Comprehensive understanding of the practices, processes, and requirements of clinical monitoring
  • Strong judgment, decision making, escalation, and risk management skills
  • Effective oral and written communication skills, including English language proficiency
  • Capable of evaluating own and team members workload against project budget and adjust resources accordingly
  • Strong financial acumen and knowledge of budgeting, forecasting and fiscal management
  • Strong attention to detail
  • In-depth understanding of relevant regulations e.g. ICH/GCP, FDA guidelines, etc.
  • Strong computer skills to effectively use automated systems and computerized applications such as Outlook, Excel, Word, etc.
  • Capable of independently managing clinical only studies


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 have a flexible 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 a global 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.

Due to the high volume of applications received, only shortlisted candidates will be contacted.

*LI-MP1

*LI-MP1

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