诚招CRA, PM, BD Account Manager

GRS_Shanghai

Company Profile:
7 y6 g! p! X5 ?$ S4 B+ cGlobal Medical Consulting Services (Shanghai) Co., Ltd. is a wholly owned subsidiary of US-based Global Research Services, LLC (GRS). GRS has offices also in Langenfeld, Germany, Warsaw, Poland, and Montreal, Canada. GRS is a leader in the management of clinical research programs for the pharmaceutical, biotech, and medical device communities. The company provides a full range of consulting and clinical trial management services that include protocol design, project management, data management, clinical site monitoring, biostatistical analysis, and medical report writing.7 q9 a( l0 Z' S7 l5 x" p9 s* I

' n& F1 j- C: L+ A! lContact Information:
( d" ?1 h: \! L- \) c/ ~E-mail: Shanghaihr@grs-cro.com
0 H7 Q4 C; D3 O- W, `www.grs-cro.com
$ H4 \( l4 K0 p5 s% r1 J7 ~! g
1 [9 h* \( @8 d& d) Z$ dClinical Research Associate (CRA)临床监查员! v6 o8 f/ p2 ?$ W
+ V* j3 ~8 W2 p% o7 H% |# z2 u
Position Description:
2 T- v# H# D8 z# `1 ]- Perform clinical site monitoring and collect/manage clinical research documents, including Protocol, clinical case report
5 ~3 M6 i( ^7 w: Y  ?/ eforms, Patient Informed Consent Form (ICF), Investigator Brochure and Clinical Trial Related Documents;) C- s. p' ]' O7 L! e$ ?# R
- Set up and archive Trial Master File (TMF);
" w) w" O! I8 w9 _2 W; N- Review protocol and Investigator’s Brochure;
, g" O9 a0 H5 i3 z- Check protocol against CRFs and ICF;
; b' r/ U% Z1 ]5 q. h1 C- Translate clinical trial related documents, such as protocol, ICFs, etc. when needed
9 s9 v$ {9 S9 a" D1 M; |- Prepare study guide and study logs;) r. F$ r1 H: n) O- X0 J. d( s
- Assist in preparation of protocol trailing program for investigators and study personnel;3 h7 w* ]6 d: l1 p$ W
- Communicate with Investigators and Institute Review Bord(IRB) or Ethical Committee;. a3 }' j, ?3 P
- Obtain the approval letter(s) from IRB or Ethical Committee for clinical trial(s);
; H2 Q0 K" f$ N9 i( f" N1 y- Deliver clinical supplies to clinical research centers; 2 t5 P( E/ c/ q  p! R
- Visit clinical research centers;0 q7 W4 ^  {# ]6 F6 b
- Monitor clinical Trials;
6 z: \! Z" j( K+ K- Write monitoring visit report after each visit;* `8 I  x( }2 u6 w
- Assist in organizing and facilitating Investigators’ Meeting ( @/ A& P5 S% S* g3 N0 y3 i
- Assist in handling and report of serious adverse events (SAEs);
+ Y3 b& O$ O. q4 z- Assist in processing annual safety report for ongoing clinical trials;
( a6 Q# P4 ]& R) G7 p5 L+ F, j% i- Identify and solve problems in clinical trials; 1 X$ h/ U# s6 {( s

. ^, Z: I: c: e' z3 }Requirements:
& j: F+ Z  R1 }. Z  U8 g
# c2 {- q  n. m& ^5 u- Medical degree or BS in healthcare-related science. MS or above welcome.. y/ ]1 f' J* N( w7 x$ ?
- 2 years clinical practice in Internal Medicine, especially in Cardiovascular, Oncology, and Infectious Disease.
+ [# J" \0 g5 ]& v. Q! B, E- Minimum 2 years of CRA experience or worked as a study coordinator at study sites.: M7 c" J9 F. k3 t  J; \( F
- Good command of English, including reading, writing and speaking.
1 p( K1 v+ t  E0 g  z7 e- Good computer skills including MS Office, Outlook and Internet usage.
1 F/ K0 ]) x5 b1 F
' S1 r$ O3 Y% ~6 @Project Manager 项目经理3 j# Y4 [/ p7 Y
  ~) u; k. ^6 K; T- G
Position Description:" U9 [8 S  e% C# q, G; Y% R
The Project Manager (PM) leads the project team in development strategy design process and its execution for a clinical trial, optimizing metrics including risk, cost, quality, and time tradeoffs consistent with a sponsor's objectives. Monitors the project development process and ensures that key requirements and milestones are identified and met. Serves as the point-of-contact for cross-functional communication and tracking.
9 E  m- z4 Z" N8 w$ K6 F7 qTravel Estimate: < 25%0 r. g  `0 K$ ]0 S* t

- y! @" h4 m! U% `) WResponsibilities Include:
' n% W9 X. `9 k+ Y1 L+ r- F-Develops a broad knowledge of drug/device development trends.6 ^$ M* N% @; P' G! t/ c& C, o6 _
-Leads project team in designing and executing development plan for a project.
" h; }5 I6 u: d0 F. A. W- n-Leads project team in developing common mission, goals, commitment, and standards of behavior.
. P5 d7 c2 U0 N& a0 d-Collaborates with sponsors to ensure that all relevant scientific issues and opportunities are addressed in project plan.
& g& X3 b# \- ~" i8 Y2 ~-Assures that the conduct of assigned clinical research studies are completed in accordance with relevant corporate SOPs, FDA and local regulations, and GCP/ICH guidance documents.
% d# k  K3 t& }/ H" ]" k/ g& `' Q- Manages resource constraints, risks, and conflicts, which could impact the project timeline, quality, or budget. Develops and implements plans to minimize their impact.4 K' n1 b% T. F" H1 V3 ~' l; b7 x
- Manages cross functional groups to ensure effective communication, and on-time, on-budget completion of contracted tasks.$ X% \( p( H  N, G9 v3 Z; P2 U& L- G  v
-Coordinates the management of all financial aspects of the clinical trial with other project team members, including budget expenditures and change orders.: Q0 U7 u3 O+ H0 l
-Reviews original budget tracker for compliance with scope of work and then maintaining the budget tracker on a monthly basis.- t- m$ _+ \% O! o
-Participates in proposal development and in investigator and sales presentations.3 U/ A2 {- o* Z2 e0 i9 p, e
-Documents project team's activities accurately through minutes, plans, and recommendations.1 i$ q5 f! P) \5 {
-Manages the project team to complete all contracted tasks, including activities associated with third-party vendors and internal functional groups.
% Y* ^8 K2 i6 C' A! T# G-Other relevant duties assigned for which the incumbent is qualified.
4 F! M$ H* H2 v& f9 O- C6 B; k- ~, w# D: o
Requirements include:
/ E6 P7 ^0 \4 Z-Medical degree and two years of experience in the management of clinical projects or equivalent education and experience.
$ t, I. X0 q. O# x" h# a# k0 L$ l1 g" v-Demonstrated ability to manage budgets and personnel.
) D+ N1 V* c7 ~% J. ?/ t-Demonstrated ability to work successfully in a team environment requiring matrix management.
$ X9 p! n- }( U! M8 @+ P-Demonstrated ability to evaluate and critique scientific reports and literature relative to drug and device development.' W2 B% i8 o4 C, b3 O9 U
-Demonstrated knowledge of FDA regulations and requirements governing the conduct of clinical trials including GCP and ICH." E$ q/ S7 r6 ]8 ?! c4 z! r
-Demonstrated ability to make effective presentations in public settings.
% a$ b5 a2 E. T# Y-Demonstrated ability to interact with clients on sensitive issues and handle concerns appropriately.
/ ~' ~2 v4 J  Z' F-Experience with team building and conflict resolution desirable.
/ s( t! z2 K9 ^7 e-Demonstrated skills in oral and written communication in both Chinese and English.
  ]6 d5 A5 V1 q$ I% B-Demonstrated computer skills including MS Office and Internet usage.
1 ]8 R" U6 V$ {) m1 d/ K% q+ q
! Q7 _9 j& h4 s) p$ D  VBD Account Manager 营销项目经理
. t( O. Y: f* c6 Q3 w$ b& L+ n( ~  D
Position Description:2 b2 u6 c: w4 u
The BD Account Manager is responsible for selling full clinical research services (Phase I-IV) as well as Shanghai Biometrics Center services.
7 U. S, [8 N; s6 Y& C1 [$ a6 u2 Y4 z$ E  `
Responsibilities Include:" |& Z$ Q/ A9 I  e# ?- c
-Meets and/or exceeds annual sales targets.
3 w4 n- o( e9 t& Q3 U-Identifies, builds relationships, and closes business with new and existing clients." s$ n) ?- i; b) N$ n* v
-Aggressively pursues clients for new business sales opportunities.
5 d9 @' G! F0 M  y0 L- Y-Assists in the representation of our company at trade shows when needed. $ S1 R2 w" X. |5 n
-Keeps database for client leads, accounts, and opportunities updated.3 s8 X! F8 {8 P& i+ ~4 ]$ |
-Gains appropriate input to proposal from client and ensures that the final document addresses client needs and requirements.
4 E1 d, \$ Q* F-Works with Proposal Manager to ensure deadlines are met and the proposal addresses client decision-making criteria.
" V7 ~6 e" b9 x-Maintains contact with clients during the life of each accrued project and provides feedback to the Project Manager and senior staff on client satisfaction.
9 t5 H+ G. n) A& g* U-Prepares/maintains required reports.
1 G3 B% p9 O5 \1 I7 F5 Z, k, A7 q5 j) w5 k7 P1 T% `* t! z
Requirements include:' S+ `( K9 |$ p% J/ P  s$ v: _1 k
-Bachelors Degree with two years in a medical or technical sales field.
7 A: Y; l5 }6 |/ Y-Demonstrated experience in the management of sales-related activities as an inside/outside salesperson.
) U- b: c" W  U: @* Q4 j1 d- V  ]/ i, Y7 Z-Ability to develop a technical understanding of CRO services to ensure good communication with clients
4 F0 W2 Q* l* H. a$ {& J- |$ |-Excellent oral communication and presentation skills in both Chinese and English.
' Z# N- D# R- \  a) Z1 V' w- T6 o-Demonstrated negotiating skills.
' L) Z. E; q. n' y# g-Evidence of a personal style that builds client relationships and emphasizes high energy, collegiality, and effective teamwork.% z& P3 a  @4 ^& g  b* l4 E, _
-Demonstrated computer skills including MS Office and Internet usage.