Main?Duties?and?Responsibilities
1.?The?role?is?highly?people?oriented?and?entails?dealing?directly?with?clients?and?internal?operational?departments?for?setup?and?implementation?of?projects?including?but?not?limited?to?the?following?scope:
a.?Patient?Centric?Services?(e.g.?Home?Healthcare?(HHC)?visits,?Direct-to/from-Patient?(DTP/DFP)?shipments),
b.?Storage?and?Distribution?of?supplies?(ancillaries?as?well?as?medicinal?products,?such?as?Investigational?Medicinal?Product?(IMP),?Non-?Investigational?Medicinal?Product?(NIMP),?Active?Pharmaceutical?Ingredients?(API),?Standard?of?Care?(SoC)?Commercial?Product,?Product(s)?for?Named?Patient?Programs?(NPPs))?to?investigator?sites,?local?and?regional?depots,?HHC?providers?and?clinical?trial?participants
c.?Expanded?Access?Programs
2.?The?role?necessitates?taking?ownership?of?the?project.?This?involves?providing?the?client?with?a?primary?contact?point?and?acting?as?the?''project?owner"?to?coordinate?the?internal?operational?and?quality?departmental?roles?in?the?project.
3.?The?Project?Manager?is?responsible?for?managing?the?project?budget?and?ensuring?key?study?deliverables?are?maintained?in?accordance?with?study?contracts.?Project?activities?among?others?encompass?the?support?of?project?strategy?and?feasibility?discussions,?the?creation?of?a?Project?Management?Plan?between?Marken?and?its?clients,?development?of?additional?project?related?internal?and?external?forms?and?work?instructions,?training?of?Marken?and?external?project?stakeholders,?setup?of?involved?system?(e.g.?Marken?inventory,?track?&?trace?or?Home?Health?Care?system),?tracking?of?project?activities?and?milestones,?support?with?Quality?incidents.
4.?Other?responsibilities?include?dealing?with?project?enquiries,?preparation?and?maintenance?of?study?reports?and?KPIs,?supporting?change?order?processing?and?project?billing?activities,?assisting?in?client?audits,?developing?SOPs?and?project?forecasting.
5.?Outside?of?client?project?support,?the?Project?Manager?is?expected?to?be?an?engaged?member?of?the?Project?Management?team,?contributing?to?training,?business?process?documentation,?departmental?activities,?and?the?similar?which?will?improve?the?department,?and?Marken,?over?time.