CTC Resourcing Solutions is a specialist staffing organization providing flexible resourcing solutions to the pharmaceutical industry across Europe. They are currently looking for an Associate Director, Clinical Project Management – Oncology to lead the delivery of clinical studies through managing a team of Clinical Study Managers at a growing pharmaceutical company based in Buckinghamshire, UK. The role will be responsible for overseeing global or local clinical studies in adherence to regulations, overseeing CROs and vendors, study planning and budgeting, and people management. Qualifications include 5-10 years experience in clinical research, knowledge of clinical studies and regulations, and experience managing CROs.

1. Providing Flexible Resourcing Solutions
CTC Resourcing Solutions, founded 1997, is a pan-European specialist staffing organisation with
offices in London, Basel and Munich, providing flexible resourcing solutions to the pharmaceutical
industry across Europe, with contract and permanent placements in clinical development, data
management, statistics, regulatory affairs and medical marketing.
For one of our clients, we are currently looking for a
Associate Director, Clinical Project Management – Oncology
Reference Number: 62-949-AD-W
Type of placement: Permanent
Location: Buckinghamshire, UK
Our client is a growing pharmaceutical company with major therapy franchises in oncology and
cardiovascular medicine. The EU development headquarters are based in the UK, in modern and
spacious offices in Bucks. This role is to lead the delivery of the clinical studies through the line
management of a team of Clinical Study Managers ( CSMs). To succeed in this role, you must be able to
demonstrate skill in team leadership, influencing, relationship building and in the management of
outsourced vendors. This is a fully office-based role.
Purpose:
 Lead execution of global or local clinical studies, in adherence to Good Clinical Practices
(GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration
(FDA) regulations/EU Directive, and International Conference on Harmonization (ICH)
guidelines
 A key focus will be the oversight of, and interactions with CROs and other external vendors to
ensure studies are conducted according to the timeline, budget and quality measures set forth
by the Study team
 The Associate Director will take responsibility for the Study Management operational strategy
and overall delivery of the clinical study (i.e. Delivery Lead role). This position will have line
management responsibility of Clinical Study Managers, who are primarily responsibility for the
tactical execution of the study. In the absence of Clinical Study Manager, the Associate
Director will be expected to take both strategic and tactical roles to deliver the study
Main Responsibilities:
Study Planning, Budget and Execution
 Lead the study team to develop a cross functional, integrated study plan to study start up (in-
house), and create initial study budget. Review study feasibility assessments provided by the
CRO(s), select the CRO and provide input into ARO selection
 Validate the study implementation plan provided by the CRO through to study close out and
CSR writing. Ensure the timing of the major study milestones and the associated budget meet
the needs of the overall development plan agreed by the Integrated Project Team (IPT)
 Lead site selection and site qualification discussions with study team and CRO
 Take responsibility for incorporating the operational delivery aspects and logistics into the
protocol and lead document writing and review for the protocol and amendments. Additional
medical writing tasks may involve ICF, CRF guidelines, IB and safety communications, DSUR,
IND

2.  Lead the study team kick off meetings and subsequent team meetings (company alone or with
CRO and/or ARO meetings). Work with the Medical Lead to create the DSMB Charter, and
take accountability for DSMB (or adjudication committee) meeting management. Take
responsibility to ensure meeting logistics, agenda and minutes are in accordance with
company standards
 Oversee the CRO and provide timely input to ensure that the study is executed according to
the agreed project plan. Complete a study risk assessment and ensure mitigation and
contingency measures are prepared and implemented. Actively assess potential risks to the
study and propose mitigation plans
 Take specific accountability to oversee the quality of interim analysis prior to data base lock
(DBL) , liaise with CRO to ensure timely DBL is achieved, and ensure delivery of the CSR in
close coordination with the Medical Writer or CRO
CRO and Quality Oversight
 Responsible for management of CRO(s) performance to ensure adherence to scope of work
within timelines and budget at an overall study level. Specifically, track major study milestones
and monitor overall operational performance metrics through the life of the study. Identify
issues early and propose solutions. Whenever possible, resolve issues that have been
escalated or if warranted, take issues to the appropriate governance committee
 Create the budget at study start up, and monitor the overall agreed budget against trial
progress. Work closely with internal and external stakeholders to ensure team awareness of
the CRO scope of work (to minimize unwarranted change orders) and budget, so both can be
managed appropriately
 Provide oversight of the CRO to ensure compliance with company’s quality measures. Lead
the creation of the Quality Oversight Plan (QOP) and ensure study team adherence to the
QOP. Be aware of and be able to predict deviations or potential noncompliance concerns (at a
protocol level, site level, study level) and rapidly resolve or escalate to appropriate
Governance Committee
People Management
 This position requires the supervision of functional and/or direct reports. In addition to
providing instruction, direction of daily activities in support of goals, the supervisor will conduct
a performance evaluation against development goals and career path requirements for their
direct reports. The supervisor should coach and guide their functional and/or direct reports in
support of their development needs, and facilitate conflict resolution on their behalf.
Study Management/General
 Design, update and implement appropriate innovative and best-in-class procedures and
SOP’s related to clinical study development and execution, in collaboration with Quality
Assurance.
 Collaborate with Quality Assurance, QC function and regulatory Operations to implement TMF
quality standards.
 This position may require support to overseeing implementation of CAPA in relation to
sponsor’s audit or regulatory inspection.
Qualifications and Experience:
 A Bachelors degree or equivalent in the Sciences as a minimum, with a higher degree
preferable.
 Candidates with a nursing diploma/assoc degree with substantial experience may be
considered for this position.
 Likely to have 5 - 10 years’ experience dependent upon level of education attained and
relevance of global clinical research experience
 Experience considered relevant includes study management, clinical or basic research in a
Pharmaceutical company, a Medical device/Diagnostic company, Academic Research
Organization (ARO) or Contract Research Organization (CRO). CRA experience is preferred.

3.  Demonstrates advanced knowledge of design and phases of clinical studies on a global scale,
global regulatory issues, CRO operations, and compliance practices
 Effectively oversees, manages, and influences CROs, and builds strong relationships at the
senior levels within the CRO organization
 Manages and leads, at a junior level, clinical projects as well as management of broader
projects at a global level
 Supports and effectively multi-tasks different and complex assignments and responsibilities.
 Effectively negotiates and influences to solve high impact/scope problems.
 Understands, identifies, mitigates, and communicates risks at the study or program level.
 Effectively leads and influences within the matrix at the study level; manages functional or
direct reports.
 Sound understanding of the concepts and applications of clinical research, medical
terminology and other disciplines involved in drug development.
 Proficiency in computer applications such as Microsoft Word, Excel, and PowerPoint. Strong
oral and written communication skills.
Our offer:
 Good basic salary
 28 days annual leave
 Excellent bonus scheme
 Generous pension contribution
 Long Term Incentive Plan (LTI): share options
Should you be interested in the above position and wish to apply, please send your application with your CV,
quoting the above reference number, to our recruitment team at recruitment@ctcon.ch
CTC Resourcing Solutions, 117 Waterloo Road, SE1 8UL, London, UK
Tel.: +44 207 193 9972 www.ctcon.ch info@ctcon.ch