Clinical Study Program Manager
- Company
- Planet Pharma Staffing Limited
- Ort
- Munich (Stadt), Bayern
- Gehalt
- Per Annam
- Veröffentlicht
- Freitag, 18. Juni 2021
- Ablaufdatum
- Sonntag, 18. Juli 2021
- Ref.
- JS - 345734
- Fachbereich
- Klinische Forschung, Klinischer Programmmanager, Klinischer Projektmanager, Klinische Dienstleistungen, Projektmanagement, Klinisches Projektmanagement
- Stunden
- Vollzeit
- Vertragstyp
- Festanstellung
- Erfahrung
- Erfahren (keine Management-Erfahrung)
JOB SUMMARY
As clinical Study manager / Clinical Program manager you will be responsible for all clinical operational aspects pertaining to planning, start-up and management of assigned clinical Phase I and III trial, septically a Phase 3 biosimilar study in dermatology.
********* Will Consider Strong, Lead CRA & SCRA***********
Your Tasks and Responsibilities will include.
- Identification, selection, and management of external service provider and CROs
- Organizing and facilitating study team meetings and telephone conferences with external service partners
- Co-development and review of study documents e.g. study protocol, informed consent form, monitoring guidelines, Case Report Forms, regulatory authority submissions
- Overseeing and regular reporting of study progress to ensure successful completion within agreed timelines/ milestones and budget
- Interactions with Regulatory Affairs, Drug Supply, Drug Safety and other relevant corporate functions or external development partners
- Develop and control agreed study budget
- Development of Standard Operating Procedures (SOPs)
- Plans and actively contributes in GCP audits and inspections
- Responsible for filing and maintenance of study/project documents
REQUIREMENTS
- University degree or equivalent
- Solid operational experience in Clinical Research for a minimum of 5 years on a global level
- Proven track record of ICH-GCP training
- Team player with solid project management skills to lead assigned clinical trials as a member of an international project team
- Excellent computer skills
- Excellent oral and written communication skills in English (primary language in the team
LOCATION
Location: Munich (Ideally 2 days per week)
DURATION
Permanent
SALARY
Competitive
ABOUT PLANET PHARMA
Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its headquarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering.
Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognised by FORBES as the 17th best professional staffing firm and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing.
We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.
www.planet-pharma.com
TO APPLY
- If you would like to discuss this vacancy further or to discuss your career options in confidence, please telephone on +44 (0) 20 3928 8388 or e-mail on jsmith@planet-pharma.co.uk
- If this role is not suitable for you, please let us know if you can refer anyone – any recommendations are much appreciated! Planet Pharma offers a competitive referral scheme so you will be rewarded for your help!
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