GLOBAL FEASIBILITY LEAD
Closing date for applications: 31 July 2021
MAC is a full-service global Contract Research Organisation (CRO). We also own a network of research sites. Our mission is to serve with honesty and integrity to make an outstanding contribution to human health.
We are seeking to appoint a Global Feasibility Lead to join our Clinical Operations team and make a positive impact in a growing and progressive CRO. You will be joining a company that put the needs and wellbeing of their people first, who are inclusive and who deliver exceptional service – together.
This role is full time and is homebased with business related travel as required.
The purpose of this role is to manage assigned projects, including pre-award efforts and post-award Site Identification assessments, from the Request for Proposal stage through to the end of the feasibility assessment, delivering accurate and data-driven strategies to drive a successful study endpoint. The Global Feasibility Lead ensures all work in the remit is conducted in accordance with ICH-GCP, all relevant local regulations and MAC SOPs/Policies.
Work with the global proposals and clinical operations groups to ensure all RFP responses reflect MAC’s best country-site strategy. Assisting with RFI responses as appropriate. Supporting the creation of feasibility budget elements.
Work with internal stakeholders to gather and leverage knowledge and insights, to support indication, project, trial (and/or country) level feasibilities.
Liaise with company experts to determine a protocol assessment, regulatory timelines, indication prevalence and patient funnels which may impact country selection and enrolment rate and develop comprehensive feasibility reports.
Develop and presenting country and site strategies by researching and analysing data, developing strategy, writing proposal text, participating in bid defences and kick-off meetings and serving as functional bidder for assigned RFPs.
Informal feasibility which may require the contact of known sites to garner feedback.
Lead awarded feasibility offerings by confirming or revising the country and site strategy and scope of work through discussions with the client and cross functional team members, overseeing creation of the optimal site profile, creating site assessment surveys, reviewing data from sites, determining parameters for tiering sites and providing PSV recommendations.
Lead cross functional teams to coordinate trial optimisation efforts and to be accountable for final report deliverable and presentation to the client.
Translate feasibility assessment data/results into visual presentations and/or written reports, as required, and delivering to internal/external stakeholders in the determined forum (e.g. client or team meeting).
Create, compiling and maintaining the MAC Site Database, recording identifying information, metrics and aspects of site performance that will assist with site strategy and selection choices.
Ongoing training and orientation with Global Data and clinicaltrials.gov and other relevant tools to ensure proficiency in data mining.
Own and maintaining MAC’s bespoke enrolment prediction tool.
Life Sciences degree or equivalent and relevant formal academic / vocational qualification.
Previous clinical research experience, including background with feasibility, that provides the knowledge, skills, and abilities to perform the job. Minimum of two years in the feasibility area of clinical research.
Hands on practical previous experience of pre and post award feasibility activities.
Practical experience and understanding of global drug development and clinical trials including demonstrated experience for the mining, manipulating and presenting of complex scientific data as it relates to clinical research and market analyses.
Skills in data mining and be “curious” in nature.
Excellent independent judgment and decision-making skills
Adept at analysing data to form independent decisions.
Excellent oral, written communication and presentation skills.
Capable of motivating others to define and reach team objectives.
Proven ability to make difficult decisions under pressure, at times without all desired information.
Excellent interpersonal, problem solving and conflict resolution skills.
Good leadership skills including experience leading a global and/or cross-functional team.
Superior time management skills for working within a fast-paced environment.
Be both self-motivated and a good team player.
Proficient in the MS Office suite and relevant clinical trial databases.
Competitive salary in keeping with pharmaceutical industry standards and will reflect experience
Free onsite parking at MAC office locations
25 days annual leave plus bank holidays (increasing in increments to 30 days after 6 years service)
Your birthday off work
Regular hours (including Christmas Day, Boxing Day and New Years Day off)
MAC Clinical Research invites applications from highly motivated candidates, with a desire to achieve their full potential. You will be working with an organisation that sees you as an investment and is keen for you to achieve your career aspirations.
Please note that if we receive a high volume of applications this date may be brought forwards.
Salary: To be commensurate with experience. Apply Now