• Job Description

  Req#: JR137494
  Global Pharma seeks Global Study Manager in Early Hematology/ Permanent/ Home-based

  ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development

  We are currently seeking a Senior Clinical Trial Manager (Global Study Manager) to join our diverse and dynamic team. As the Senior Clinical Trial Manager, you will hold a crucial role in ensuring the successful delivery of all clinical aspects of the studies. Your expertise and leadership will be instrumental in managing the clinical portion of the budget, developing effective monitoring plans, and driving enrollment to meet project objectives. Moreover, you will liaise with stakeholders, identify and mitigate risks, and provide comprehensive reporting on all clinical activities.

  What you will be doing:

  • Recognize, exemplify and adhere to ICON's values which center on our commitment to people. Clients and Performance.
  • As a Professional, the employee is expected to recognize the importance of, and create a culture of, process improvement with a focus on streamlining our processes, adding value to our business, and meeting client needs. Actively identify opportunities for process improvement. Lead or participate in process improvement initiatives, as assigned, and promote the sharing of best practices.
  • C on tri b u te to t he d evelo p ment of st udy d o c umen ts as appr o pri a te as we ll as any u pdates/amen d men t s, ensuri ng t em p l a te and vers i on c om pl ian c e.
  • Lead t he p reparation of c o u n try spec i f ic agree men ts, c onf i den t iali ty ag r eemen t s, c lini cal tri al app li cations and o t her a ppli cab le c o un try d o c umen ts.
  • Manage t he set-up of t h ird-party ven d ors assess i ng i n i t ial state ment of w ork and b udg e t, as we ll as t he c hange order p r o ces s.
  • Pro v i de i n put to data man agement d o c u men ts (e. g. C ase Rep ort Fo r m, Data Vali dat ion
  • S p e c ifi catio ns), a nd i n terface w i th data manag ement represe n tat i v es a nd si tes to fac ili tate t he d e li very of st u dy dat a.
  • I n i t iate c o n tract /budget requests and t r a ck o n g o i ng s tat us; fac ili tate generation of purc hase orders, rev i ew vend or i nv oices and assist in tracki ng spend against app r o ved b udg e t.
  • E nsure t he su p p ly of In vest igat i o n al p r o d u ct and st udy materials by l iai s i ng w i th Drug S u pp ly or external serv i ce p r ov i ders as app r o priat e.
  • O versi ght of t h ird party v e nd ors, g l obal / lo cal i n ternal staff and i n v esti gat or s i tes to supp o rt
  • effe ct i ve d e livery of a st udy a nd i ts r e g u lat ory d o c umen ts from d e v elo p ment of t he pr o t o c ol t h r o ugh to the Cl i n i cal S t udy Rep ort.
  • Pro v i de o vers i ght of and su p p ort r e cru itment and data de li ve ry as we ll as ri sk m i t i gat i on strat e gie s.
  • Assist in t he c li n i cal trial i n suran ce p r o cess; tra ck ap p r ovals, revisio ns a nd renew a ls of cert ificate s.
  • M o n i t or st u dy c onduct and p r o gress, p r oac t i vely i den t ify i ng and res o l v i ng issues w h i ch m ay i m pact d e li very of t he st u dy to t he ne cessary quali ty, t i me lin es or b udg e t.
  • S u pp ort r isk manag ement and quali ty eff o r ts to ens u re st u dy c o m p li a n c e.
  • S u pp ort set-up, mai n tenan ce, close o ut a nd ar c h i ving of t he Trial Master File (TMF), e n s uring c o n t i nual inspection read i ness.
  • Prepare p rese n tation m a te r ial f or me et i n gs, n ew s l ett ers and w e bsi te s.
  • S u pp ort the st u dy team in the im plemen tation of a ud i ts and re gu lat o ry inspectio n s.
  • C on tri b u te to re v i ew of n e w /amen ded / un i q ue S O Ps a nd gu i dan ce d o c umen t s.

  
  Your profile:

  • U n i versi ty d e gree / Bachelor’s d e g r ee, preferably i n me d i cal or biolo g i cal s c i e n ce, or d iscip li ne asso c iated w i th Cl i n i cal Res earc h, or equ i valent exper ien ce
  • M i n i mum of 3-4 years of p r o gressive cli n i cal trial experien ce
  • Must have global experience
  • Experien ce of w o rki ng w i th and d e li v e r i ng t hrough strat e g ic part ners and 3rd party ven d ors
  • Early Phase experience
  • Hematology experience is desirable
  • Excel lent kn o w ledge of I C H-GCP pri n cip les
  • Team orien tated
  • A b i l i ty to c o ord i n a te and p r i ori t ise m u l t i p le tasks and d e li verab l es
  • Proact i ve ap p r oach
  • H i gh d e g ree of fl exi b i l i ty D e m o nstrated verbal and wri tten c o m m unication skil ls
  • Good n e go t iation a nd coll ab oration skil ls
  • D e m o nstrated i n terpers o nal and p r ob l e m- solv i ng sk i l ls
  • So me tra vel m ay be re quired

  What ICON can offer you:

  Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

  In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

  Our benefits examples include:

  • Various annual leave entitlements

  • A range of health insurance offerings to suit you and your family’s needs.

  • Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.

  • Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.

  • Life assurance

  • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.

  Visit our careers site to read more about the benefits ICON offers.

  At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

  If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here.

  Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

  Are you a current ICON Employee? Please click here to apply

• About the company

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